Beyond Approvals: Establishing a Patient-Centric Approach to Biosimilars


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Content provided by Celltrion. Copyright 2023 and published by MJH Life Sciences®. No portion of this program may be reproduced or transmitted in any form, by any means, without the prior written permission of MJH Life Sciences®. The views and opinions expressed in this material do not necessarily reflect the views and opinions of MJH Life Sciences®, or Managed Healthcare Executive®.

The selection of biosimilar medicines in the United States is growing rapidly, offering patients and providers many choices for high-quality, low-cost medicines to treat a wide range of diseases. The Food and Drug Administration approved eight biosimilars in the past 15 months alone, including three versions of Humira® (adalimumab), the best-selling drug used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis and other inflammatory diseases. Not to mention, there are more than 35 biosimilars in the U.S. pipeline, according to the “2023 Biosimilars Report” by Cardinal Health.

The market entrance of so many new biosimilars is good for the health care system because greater competition helps to lower costs, thereby increasing the accessibility of these critical treatments. The need to improve the affordability of biotechnology treatments is clear: Pricey biologic medicines account for 37% of total prescription drug spend in the U.S., even though they make up only 2% of total prescription volume, according to research by RAND Corporation.

In recent years, the U.S. regulatory landscape has supported market adaptation and growth of biosimilars to help deliver savings to providers and patients. In 2021, President Joe Biden signed the Advancing Education on Biosimilars Act, which authorizes the FDA to educate the public about the benefits of biosimilars. President Biden also signed the Ensuring Innovation Act, which strengthens the ability of the FDA to limit exclusivity periods on new drugs, so biopharmaceutical drug makers can’t automatically avoid competition from generics for five years.

As for adalimumab biosimilars, two major PBMs, OptumRx and Express Scripts, have issued public statements indicating that they plan to cover both reference adalimumab and several adalimumab biosimilars once available. Assessing the pros and cons of a potential patient transition will become increasingly important for patients and providers. Having a stable supply chain, comprehensive clinical data, product differentiators (e.g., citrate-free, concentration differences, drug administration), presence of an interchangeability designation and engaging, effective patient support programs would all be relevant to assessing the manufacturers’ approach to incorporating patients’ perspectives and preferences.

Data from clinical trials helps providers and patients have better confidence in biosimilars by assuring them that the treatment options are as effective and safe as the reference products. Celltrion’s biosimilar of adalimumab, Yuflyma®*, was approved by the FDA in May 2023 based on data showing comparable pharmacokinetics, efficacy and safety compared to the originator drug. For example, in a randomized, double-blind study involving 648 patients with active rheumatoid arthritis, efficacy was highly similar among patients who stayed on the reference drug and those who switched to Yuflyma. The biosimilar and reference drug also had similar safety profiles, and switching to the biosimilar did not affect immunogenicity.

Celltrion brought Yuflyma to market in the U.S. in July, offering a valuable treatment option for providers, payers, and patients. Celltrion received the European Commission (EC) approval for Yuflyma in February 2021 and brings to the U.S. a wealth of global experience in providing high-quality biosimilar options to more than 110 different countries. In addition, Celltrion has applied to the FDA for interchangeability designation for Yuflyma, a decision expected to be rendered in Q4 2024. The interchangeability designation, if granted, will provide patients and payers with further evidence demonstrating the safety of Yuflyma and allow the product to be substituted for the reference product at the pharmacy level, without the prescriber having to change the prescription. Such "pharmacy-level substitutions" are similar to how generic drugs are substituted for brand name drugs, and is subject to state pharmacy laws, which vary by state.

Celltrion has a large and growing pipeline of biosimilars that we hope will provide even more options for providers who wish to address the unmet needs of patients using biologics. Not only do we focus on efficacy and safety, but also on patient-centric innovations such as biologic formulations designed to lower the risk of injection pain, as well as administration devices that are convenient and may lower allergic reactions, such as those that could from products made with natural rubber latex.

As the market for biosimilars expands, Celltrion will strive to put patients first and continue to generate data to demonstrate the comparability of our products to originator biologics. We believe this comprehensive approach to biosimilar development will help patients and providers make optimal treatment choices in the increasingly competitive and crowded biosimilar market.


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- Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.

- Discontinue YUFLYMA if a patient develops a serious infection or sepsis during treatment.

- Perform test for latent TB; if positive, start treatment for TB prior to starting YUFLYMA.

- Monitor all patients for active TB during treatment, even if initial latent TB test is negative.


- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.

- Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

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