Biosimilars and My Experience with Them

Information in this article is for educational purposes only. This article reflects personal experiences and is not meant to diagnose or treat any disease or illness. This article is not sponsored and you should consult with your medical professional about any information related to your medications.

Biologics are drugs derived from natural resources and manufactured by various biotechnology methods. They can benefit patients with rheumatologic diseases, inflammatory bowel disease, malignant conditions, etc., by halting disease progression, alleviating symptoms, and improving quality of life. Biologics are one of the top-selling drugs worldwide. Still, the high cost of this drug is a major drawback, so it remains unaffordable and inaccessible to many patients. 1

Biosimilars are non-innovator or copy products of the original biologic drug. More notably, they are cheaper. The development of biosimilars allows for broader and necessary access to these medicines because of their lower cost and hence greater affordability. This improves cost-efficacy ratios and access to these drugs. India is one of the leading manufacturers of similar biologics. 1

Exemptia is a biosimilar of Adalimumab which often goes by the original brand name - Humira. Exemptia is a TNF inhibitor and anti-inflammatory drug manufactured and promoted by Zydus Cadila, in India. The dosage depends on the severity of the case.

I was prescribed Exemptia in 2016 when I was 16 years old. My first year with Crohn’s I was put on multiple medications, but none of them seemed to work for more than one month. Finally, after a year I was put on steroids (Budesonide). These came with their own set of issues but were able to manage symptoms for a while. Soon my body stopped responding to the steroids as well. The doctors and nurses had been extremely supportive and helpful but I was getting exhausted by the frequency of my hospitalization. I had missed 3 years of high school already and was wondering whether my life would ever go back to normal. The next step was either surgery or biologics. After a long discussion with the doctors and extensive pros and cons lists, my parents and I decided to give biologics a chance. That was the best decision we made, I was lucky enough to experience remission thanks to this medication.

Exemptia was relatively new at that time, having been released only a few years prior. Before starting the medicine, it was made sure all my vaccinations were up to date. CT scans & blood tests were done to eliminate the possibility of having any viruses or infectious diseases like TB. The first dose was 80 milligrams, and this was followed by 40 milligrams every two weeks. I have been on this medication on and off for six years. While hospitalizations were frequent during the first few years of starting this medicine, they have significantly reduced now. One of the biggest benefits I saw from this medication was that it brought normalcy back into my life.

I am now an undergraduate student and it's very important for me to stay on top of college deadlines, my biosimilar helps me achieve that. The administration of the injection is relatively easy as well since it's a subcutaneous injection or an injection under the skin. My recommendation would be to get a friend or family member to help because it does hurt while the medicine is entering the body. However, I have been lucky enough to not experience any side effects right after the administration of the injection like fatigue or soreness. Like any other medicine, there is a downside to this too, including recurrent infections and problematic storage conditions of the injection. The injection should always be kept at a temperature between 2-8 Centigrade (35-46 degrees Fahrenheit), which is rather challenging to do while traveling or living away from home. However, overall my experience with this medicine has been very positive despite its drawbacks.

Resource

1. Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy & BioAllied Sciences. 2019; 11(1): 12-15.

This article was written by Varada Srivastava from India.

Photo by Damir Mijailovic from Pexels.

Learning to Center Myself in my IBD Journey

By Ibrahim Z. Konaté from the United States and France.

Featured photo by Africa Studio/"Shutterstock.com

Disclaimer: Nothing said in this article is medical advice. Seek professional advice from your care team before making any changes to your nutrition plan.

---

Food was my gateway back into my culture.

As a first-generation American, the narrative about my identity has usually been out of my control, and like so many others in my situation, I decided to focus my young adulthood on unpacking this conflict and reconnecting to my roots.

Growing up between France and Virginia, I knew Mali only through stories, pictures, and most importantly, food. When I left home for graduate school, I made sure to ask my mom to teach me all of the family recipes.

The comfort provided by these meals was essential in my life, especially leading up to my diagnosis of Crohn’s Disease while in isolation from my support system in 2020.

The initial relief I felt from receiving my diagnosis after years of experiencing symptoms was immediately followed by shock at the absence of global cuisine in IBD medical and advocacy materials. I started worrying - could it be that my culture and my identity as an IBD patient were incompatible?

There seemed to be no room for me in the IBD community because fundamental components of myself were either excluded from the conversation or labeled as dangerous. This feeling was amplified through many virtual cooking events that I attended and with most IBD-specific recipes that I found online.

It seemed as though a lot of IBD advocacy spaces were focusing on a specific lived experience and I wanted to make sure that everyone had space to center themselves within their own disease journey.

In recent years, the incidence of Crohn’s Disease and ulcerative colitis has been increasing across all demographics in the United States, with a markedly high increase for BIPOC patients. With the increasing diversity in the IBD community, it is imperative that we continue to build a space where everyone can be accepted, no matter who they are.

As a newly diagnosed Crohn’s Disease patient, I was able to meet with a nutritionist at my local IBD Center. I came out of this appointment with a lot of information about the Mediterranean and low FODMAP diets, and a list of recipes that were all inspired by western European cuisine. I decided to take the advice of my nutritionist to incorporate this Mediterranean diet into my life, but first, I wanted to break it down into its components and see if I could build up a regimen that looked more like myself.

Separating this culinary concept from its name and origin allowed me to deconstruct and generalize it into high fruit, vegetable, fish, olive oil, and whole-grain intake. Once I had these parts, I found myself able to create the dishes that my mom had taught me before I left home. There were of course minor substitutions, but the essence of the recipes and the culture that they represent were still present.

I started challenging myself to see if I could make my new dietary accommodations fit into my culture and hoped that this revolution in myself would allow others to steer their experiences in managing their condition.

This February, for Black History Month, I walked around my home of Harlem in New York City to explore food from across the African Diaspora that may fit into the deconstructed diet guidelines provided to me by my nutritionist.

Here are three dishes from local restaurants that align with the guidance from my care team or can be slightly altered to avoid trigger foods.

---

Gumbo - American South - Miss Mamie’s Spoonbread Too

Gumbo is a thick okra-based stew that is native to the American South. It is the official plate of the state of Louisiana and has Creole and Cajun varieties. Creole gumbo tends to have seafood, dark roux, and filé powder from the sassafras plant. Cajun gumbo typically incorporates chicken, but variations will be found for both of these recipes in different households. There is often the presence of onions, bell peppers, and celery in this stew, but any of these can be omitted or substituted if they risk triggering a flare-up.

Mafé - West Africa - Teranga

Mafé is a sauce made with peanut butter and tomato sauce. It is usually served over rice or couscous with meat. At Teranga, they prepared it with chicken but this can be served with a vegetarian or vegan substitute.

Jollof rice is also native to West Africa (my mom says that it's absolutely native to Senegal but every country seems to have its own variation and claim to the recipe!). It gets its bright red appearance from tomato paste and spices. I grew up eating jollof rice almost exclusively with fish, but it pairs well with other meats and vegan options as well. The trademark flavor can still be obtained by excluding any spices or peppers that may aggravate a flare-up.

Plantains - Africa, Caribbean, Latin America - Homemade, bought from a local market

Plantains are a fruit related to the banana that exists all over the African Diaspora. It is an incredibly versatile dish that can be a snack or an entire meal. I grew up eating them fried in oil but there are other recipes that prepare them by roasting or even with an air fryer.

This experience has taught me the importance of representation. That being a person with IBD and honoring my origins are two experiences that can coexist. In fact, prioritizing my customs allowed me to have better control over my relationship with my diagnosis.

I encourage you all to think about what traditions make you who you are today. If you do not see yourself celebrated in the diversity that is our IBD community, center yourself and find others who will support you and cheer alongside you as you make this a space where we can all be our authentic selves together.

---

This article is sponsored by IBD Strong. IBD Strong is a volunteer grassroots organization that provides a community of hope, connection, inspiration and empowerment to children, teens and families living with Inflammatory Bowel Disease. They believe that every individual diagnosed with IBD deserves hope and opportunities to thrive. IBD Strong’s mission is to inspire and empower individuals living with IBD to not let the disease define them.

IBD in College – Put it on your Resume!

“It was a burden that I hated and equated as the worst part of myself. From the ages of 3 to 19, I treated it as this deep dark secret that I told no one about.”

I used to think that confident people were born confident, brave people born brave, and happy people born happy. An immature thought, but I believed characteristics like these were just naturally inherent. I convinced myself that I was just born to be sick with my IBD. It was a burden that I hated and equated as the worst part of myself. From the ages of 3 to 19, I treated it as this deep dark secret that I told no one about. For some reason, it was virtually impossible for me to tell friends about my UC and how it affected me. I kept everything to myself and never shared when I was feeling physically sick, or even worse, mentally drained. Luckily, I have a great family, an unrelenting support system that even when I didn’t want them to be, they were there for me. However, when someone with IBD goes to college, either newly diagnosed or a long-time patient, their assumptive world shatters. You’ve moved miles away from home with the most annoying friend you could ever think of, your IBD. At least that’s what I thought when I got to school. How am I going to deal with it? Am I going to tell people? Will they think I’m weird? What do I eat? What if I must go to the bathroom in class?

The questions were looming over me the minute I got to school. My fear overwhelmed me; it convinced me to believe that I would never find a way to integrate my UC into my new college life. I was fighting this mental battle against myself, and simultaneously seeking to get involved in any sort of organization at my school to feel more comfortable there. My university happens to be heavily research focused, and I was interested in the healthcare field. I decided to push myself out of my comfort zone and join a lab that focused on the one thing I knew the most about, IBD. It was there, in that moment that I felt empowered by my disease for the first time. I chose to openly use my IBD as a qualification, as an asset rather than a detriment. As time went on, I started to get more involved in other organizations that focused on IBD, such as this fellowship, that views one’s IBD as a contributing factor rather than a limiting one. I took a part of myself that I once hated and allowed it to become a distinctly unique piece of me. The transformative growth I underwent from concealing my IBD to using it to make me stand out was an unparalleled feeling.

“I am continuously seeking out ways in which I can intertwine IBD with my life, my work, and my interests.”

My biggest recommendation for anyone in college with IBD is to put IBD on your resume! Not literally, but in your own rhetorical way. Have it be your secret superpower that allows and pushes you to get involved in opportunities that reside in a world you so deeply understand. Work with nonprofits for IBD, get involved in research, or join a support group. Apply for scholarships for students with IBD. If you don’t happen to find any opportunities for students with IBD, start some! Start a support group or start a club exclusively for college students living with IBD. Find absolutely anything that connects you to your disease, because the minute you do this, you start to not only view your disease, but your potential, in a different light. If we as IBD patients are going to live with this forever, we might as well use it in a way that gives us the upper hand. Live a life with activities that are filled with opportunities that let you be proud to be someone with a chronic condition. Four years ago, I would have never been able to muster up the confidence to talk about my disease in the way I do. Today, the version of me that exists cannot stop talking about it. I am continuously seeking out ways in which I can intertwine IBD with my life, my work, and my interests. Every day, reaffirming that my IBD is the part of myself I am most proud of. Don’t let IBD hold you back from finding opportunities that make you feel fulfilled in a way you might’ve never known existed; use it to your advantage. It is a piece, that once embraced, can be advantageously employed in a surprisingly positive way.

Storytelling for self-growth

Have you ever wondered why someone shares their stories with strangers? Regardless of the outlets people use to tell their stories, we see storytelling get used as a catalyst for change. It is a tool that most change makers are using today; that was my initial motivation to start telling my story, until I learned the true potential of storytelling. I was just beginning my fourth year of medical school. With the stress of the upcoming qualifying exam and family moving away for work, I thought the abdominal pain I had started to experience was just anxiety. Although I am fully aware of Crohn’s Disease and its symptoms, I tried to get quick solutions to resolve the symptoms.

“Regardless of the outlets people use to tell their stories, we see storytelling get used as a catalyst for change.”

From a young age, I was told to pull myself together and not show vulnerability, which was why I suffered for eight months before getting my diagnosis. I knew what the disease was, the medications I needed to take, and that it was a chronic illness with no cure. But accepting that was one of the hardest things I ever had to do. A lot of factors played in truly accepting my diagnosis and make the decision to be more knowledgable as an IBD patient, but the major one was reading stories of other IBD patients. It opened up my mind to the possibility that I could lead a normal life. That was why I started to share my story, to be an inspiration to others.

“From a young age, I was told to pull myself together and not show vulnerability, which was why I suffered for eight months before getting my diagnosis.”

Living in Ethiopia, where most doctors state that IBD is rare, I knew I needed to speak up. I needed patients to know that they are not alone and I needed to communicate with my medical community that it is not so rare. I am glad I decided to be open about telling what I went through and how I am coping with IBD and it is not for the reasons you think. Sure, I am grateful to be able to make a change; I am happy my story is inspirational to other Ethiopians and non-Ethiopians alike. However, I am so thankful for what storytelling did for me.

“Through storytelling, I learned acceptance.”

I was not in remission when I started nor did I had a clue about managing IBD as a patient. I started only 2 years into my diagnosis and did not fully accept my diagnosis at the time. Through storytelling, I learned acceptance. As I shared my story more and more, it made me want to learn more about how to manage my condition. It also helped me step back and see how far I have come because telling my story means going back from the beginning and share the how, the why, the what of each and every detail. If there is one thing I want you to takeaway from this, it is that it doesn’t matter how much you know about something, speaking about your experience is not just so others can learn from you, it is a tool to aid in self-growth and reflection. Storytelling did not change my Crohn’s Disease diagnosis or all the hardship I faced, but the story helped me, the teller, transform and grow.

AIBD 2021: Session III: C - Innovations and Approaches in IBD Care for Children With IBD

Disclaimer: This article was written after attending AIBD 2021; all information is presented as an attendee to the conference, not as a presenter.

While I was looking forward to pretty much every presentation at AIBD, I was especially interested in Session IIIC: Innovations and Approaches in IBD Care for Children With IBD. With an all star lineup of presenters including Dr. Eric Benchimol, Dr. Lindsey Aldenberg, Dr. Sandra Kim, Dr. Andrew Grossman, and Dr. Kevin Mollen, this session was a must see for me. Not only were the presenters themselves exciting, but their topics explored the growing world of pediatric IBD management. There was a lot of information, so I’ve decided to summarize the presentations in this session and highlight the key findings and takeaways.

Pediatric IBD Year in Review

Presented by Eric Benchimol, MD, PHD, FRCPC

Dr. Benchimol had the herculean task of presenting a yearly review of 2021 in just a 20 minute time slot, and he nailed it! Some of finding over the last year include:

• COVID 19

  • Lower risk of severe COVID-19 in patients on a biologic

  • Higher risk of severe COVID-19 in patients taking steroids

  • Patients reported high amount of fear regarding developing COVID-19 and attending medical facilities

  • Evidence suggests a third dose of the COVID-19 vaccine will likely be needed to maintain antibody levels in IBD patients

• Growth in children with IBD has improved over the last 10 years

• The racial disparity between steroid prescriptions in black and white children has lessened dramatically over the past 10 years

• The STRIDE-2 publication better defines targets of treatment in pediatric IBD

Diet and IBD: Translating Research into Real-Life Practice

Presented by Lindsey Aldenberg, DO

Dr. Aldenberg presented on my favorite topic: diet and IBD. I was so excited to hear this talk, and even more excited to share the key takeaways with you below:

• The incidence (number of new cases) of IBD is increasing worldwide, and closely mirrors industrialization

• The genetic contribution to the development of IBD is at most 30-40%; this leaves environmental factors, including diet, to make up the remainder

• The gut microbiome is dysbiotic (abnormal) in patients with IBD, and diet plays a key role in shaping the gut microbiome

• Ultra-processed foods have been associated with development of IBD in recent studies, and this may be due to food additives that disrupt the microbiome and the strength of the gut barrier

• Exclusive Enteral Nutrition is an effective therapy in pediatric IBD and is often used as an alternative to corticosteroids or as a bridge to other therapies, medication, or whole food therapeutic diets.

• The results of the DINE-CD study, which compared the mediterranean diet with the specific carbohydrate diet, showed that there was no significant difference between the diets when looking at clinical remission and inflammation.

• Dr. Aldenberg’s take home points from DINE-CD were that the mediterranean diet may be a great option for IBD patients, and both the mediterranean diet and specific carbohydrate diet might have a greater effect on symptoms than inflammation

• The Crohn's Disease Exclusion Diet was effective in lowering measures of inflammation in IBD, and there appears to be a response as early as 3 weeks in patients on the Crohn’s Disease Exclusion Diet or Exclusive Enteral Nutrition 

• There may be a subset of IBD patients who have disease that responds well to diet therapy, and this needs to be further explored with more research

Cost and Access to Care in Pediatrics

Presented by Sandra Kim, MD

Dr. Kim discussed the urgent need for better access to care for IBD patients and put a spotlight on one of the largest barriers for patients: cost. Some of the highlights from the talk are:

• If patients cannot access their doctors, treatments, and medications, then the advances we are making matter less and have less impact

• Cost is the biggest delay in receiving care as reported by patients

• Per patient costs are greater in children vs adults with IBD

• The costs for IBD patients has risen primarily due to pharmaceutical costs, of which biologics are the largest contributor

• The group most affected by financial stress are families within the 50-100k earning bracket

• Delays in prior authorizations have lead to an increased use in steroid use, which is a medication that pediatric IBD providers try to avoid prescribing

• The concept of Step Therapy/Fail First by insurers is harmful to our patients. This policy requires patients and providers to use mandated therapies rather than those that the doctor/providers believes will be most effective. This can lead to delays in the patient getting the therapy that works best for them, and may result in a longer and more difficult path to remission

• Advocacy for change in cost and patient access can be done at a individual, state, and national level

• The “Safe Step” act of 2021 will allow for a clear, transparent appeals process to request exemption among other advances. Keep an eye on this bill

• Social media is a platform we can use to advocate for lower costs and improved patient access

Don’t Be Late to the Party: When to Call Your Surgeon

Presented by Kevin Mollen, MD

Dr. Mollen touched on the importance of getting the surgeon involved early in the care of IBD patients. Some of points I found most important are:

• Many studies highlight that surgery is a major cause of anxiety for patients with IBD

• Patients often view surgery negatively prior to the operation, but afterwards view surgery positively; patients often wished that they had considered surgery earlier

• A multidisciplinary approach to surgical care has been shown to improve preoperative optimization of surgery, decrease surgical complications, and likely improve patient satisfaction

• An early consult with the patient allows the surgeon to:

  • Set expectations

  • Lower anxiety

  • Optimize the patient preoperatively

  • Plan the surgery at the optimal time

• A poor nutritional status prior to surgery is associated with prolonged hospital stay, postoperative complications, and delayed recovery of bowel function. Short term nutritional interventions may be used to improve nutritional status prior to surgery

• Any patient with UC that is admitted to the hospital for an acute flare should receive a consult from the surgeon due to the high likelihood of needing surgical interventions

• In summary, it is key to communicate with the surgeon to develop a plan based on the patient’s goals to improve patient and parent satisfaction. Surgeons are a key part of the IBD multidisciplinary team

Law School and IBD

This article was written by Savannah Snyder from Canada.

Undergrad is already a daunting and tiring experience - intense classes, homework, exams, socializing, self-care. It is insanely difficult to balance it all. Throw a chronic illness such as IBD into the mix, and it becomes even harder. As many of you know, IBD can take over your life and can make working towards your goals a challenge.

My undergrad experience was full of ups and downs, from being severely ill dealing with stomach aches, joint pains, fatigues, hospitalizations, doctors appointments and more. But, I’m here to remind you and what I wish I heard someone with IBD tell me, is that you can accomplish your dreams, even with IBD.

Ever since high school I wanted to be a lawyer. I dreamed of going to a top law school. I was intimidated by the process and knew it was extremely competitive. When I was diagnosed with IBD in my fourth year of university, I thought that goal might be out of reach for me. I had to withdraw from a semester of school and move back home. I thought “how would someone like me, with holes in their transcript and withdrawn classes, be accepted to law school? How will I be able to handle a rigorous program and career while simultaneously dealing with IBD?”

Looking back, I realized I was dealing with IBD my entire undergrad experience. Instead of gaining the freshman fifteen in my freshman year, I lost fifteen pounds. I knew something was wrong each day but continued to ignore my symptoms, until I was forced to face reality and was hospitalized with a severe Crohn’s Disease diagnosis. I was scared that if something was wrong with me, I wouldn’t be able to work towards my dreams. If I was ignorant regarding what I was feeling, it wouldn’t be true.

When I withdrew from school and returned to my family home, I put my body first. I slowly came to realize that I might as well try to reach my goals of becoming a law student. I began to study for the Law School Admissions Test (“LSAT”), and spent time studying in my bed when my energy levels allowed. I started my first biologic, Humira, was hopeful it would work in time, and I booked my first LSAT 2 months away. I contacted the LSAT admissions team and received accommodated “stop the clock” washroom and pain breaks for my test. As the test date crept up, it became obvious that Humira was not working. I had to increase my prednisone dosage. I was nervous, scared, and began to lose hope. I was upset that Humira wasn’t working for me and was scared about writing a test under these conditions. The increase in prednisone brought nausea, brain fog, mood swings, irritability, fatigue, and more. When my doctor told me I had to switch off of Humira, it was too late to cancel my test. So, I decided to write it anyway. I ended up receiving my first Stelara infusion the day before the test. I told myself, this test will be a practice - and that whatever happens… happens.

I am not telling you to support the hustle culture and ignore your body. I gave myself grace around my results. I told myself if I felt negative symptoms in any way while writing, I would stop and go home. But, I was able to do it.

I wrote the LSAT and did OK and then ended up writing it again the next fall. Stelara ended up being the medication that I’ve been on ever since. I applied to law school as an access student - highlighting the experiences I’ve been through and how dealing with an illness like IBD will make me a better law student and lawyer.

I returned for my last year of school and was able to receive accommodations for exams and classes. I took a smaller class load to balance self-care and healing myself along with my goal of graduating. I’m proud to say I was accepted to my dream law school and have just completed my first semester. Although I have dealt with flares and sickness this past semester, I have reached out to accommodation services and received support. I have advocated for myself and been able to reach the dreams I had before my Crohn’s diagnosis.

I promise you, if there is something you want to do, it is possible. A life with IBD is full of spontaneity - you may never know what’s next. But, all you can do is try. Put your health first, always, but never give up on your dreams.

Photo by Polina Zimmerman from Pexels.