Autoimmune diseases

Examining Biosimilars within the IMID Landscape

Jonathan Kay, MD, professor of medicine, director of clinical research, rheumatology, University of Massachusetts Medical School, in Worchester, MA, provided a biosimilars overview to health care professionals from across the autoimmune disease spectrum who gathered at the 4th annual Interdisciplinary Autoimmune Summit (IAS). The meeting, which ran from March 24-26, 2017, at the New York Marriott Marquis, brought together rheumatologists, dermatologists, immunologists, gastroenterologists, internists, and allied health care professionals to discuss groundbreaking approaches to treating immune-mediated inflammatory diseases.

In his talk, titled Examining Biosimilars within the Immune Mediated Inflammatory Disorders (IMID) Landscape, Dr Kay started off by giving his personal definition of biosimilars. “I define a biosimilar as a legitimate copy of a biopharmaceutical that no long is protected by patent, which has undergone rigorous analytical and clinical assessment, in comparison to its reference product; and been approved by a regulatory agency according to a specific pathway for biosimilar evaluation,” he said.

He noted that the official regulatory definition varies depending on the country. In the US, FDA defines biosimilarity as “that the biologic product is highly similar to the reference product notwithstanding minor differences in clinically inactive components” and that “there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.”1

country/organizations

Figure 1: Biosimilars in rheumatology.  In: Gravallese EM, Hochberg MC, Silman AJ, Smolen JS, Weinblatt ME, Weisman MH, eds. Rheumatology, 7th Edition. Philadelphia: Elsevier Mosby [in press].

In the lecture, he also outlined potential differences in biosimilars vs the reference biologic and strategies to ensure safe and effective treatment. Depending on the country, varying terms are used to describe this category of drugs as well. (Figure 1) He reviewed the current state of the biosimilar market across varying countries (Figures 2). Numerous additional biosimilars are in development to treat inflammatory diseases including adalimumab (13), etanercept (6), golimumab (1), infliximab (5), Abatacept (2), Tocilizumab (3), and rituximab (8).2

Dr Kay also discussed the manufacturing process of biosimilars and the US regulatory pathways for small-molecule drugs and biopharmaceuticals. He reviewed a list of biosimilar abbreviated biologics license applications filed with the FDA.

biosimilars

Figure 2

Other issues related to this category of drugs, such as switching vs substitution and pricing and varying insurance payer coverage, can make it confusing when evaluating treatment options. Dr Kay explained that a switch is equal to a transition. For example, a patient transitioned to a biosimilar after initial treatment with a bio-originator. Substitution equals interchange. “Biologics Price Competition Act of 2009 affords 1 year of exclusive marketing rights to the first biosimilar approved as being ‘interchangeable’ with the reference product. Interchange can be initiated without prescriber input,” he said.3

In many states legislation in is in various stages related to biologic medications and substitution of biosimilars.4

The Social Contract

Dr Kay suggested the global community consider biosimilars as a social contract. The potential risk to the individual of switching to a lower-cost biosimilar should be outweighed by the potential benefit to global society of expanding access to care for all, he said. “We should accept a lower cost biosimilar (as opposed to the reference product), so that medications are more widely available to all members of society,” Dr Kay added.

The potential benefits of lower-priced biosimilars should decrease the cost of treating patients; and biosimilars should be more readily available to patients who the bio-originator has been inaccessible. “Greater global access to effective biosimilars should reduce disability, morbidity, and mortality associated with inflammatory diseases,” he said.

Summary

“Biosimilars are highly similar to their reference product. The objective of biosimilar development program is to establish biosimilarity, not to re-establish benefit,” he said. “A stepwise and comprehensive comparative approach to claim biosimilarity must demonstrate a “totality of evidence” with respect to physiochemical characteristics, biologic activity, pharmacokinetics, and clinical safety, and efficacy.”

“Biosimilar undergo a rigorous regulatory approval process with an abbreviated clinical package. With many biopharmaceuticals going off-patent in the near future, opportunity exists to expand patient access through availability biosimilar,” he concluded.

—Lisa Samalonis

References

  1. US Food and Drug Administration. Guidance for Industry. Biosimilars: questions and answers regarding Biosimilars: questions and answers regarding implementation of Biologics Price Competition and Innovation Act of 2009. Department of Heath and Human Services, 2015.
  2. Dörner T, et al. Nat Rev Rheumatol. 2015; 11(12):713-724; (*As of December 2016.)
  3. gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab.
  4. gabionline.net/Biosimilars/General/Biosimilars-of-etanercept; gabionline.net/Biosimilars/General/Biosimilars-of-infliximab. gabionline.net/Biosimilars/General/Biosimilars-of-tocilizumab; gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
  5. FDA. Guidance Compliance Regulatory Information. http://www.fda.gov.
  6. National Conference of State Legislatures. State laws and legislation related to biologic medications and substitution of biosimilars. http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx. Accessed November 16, 2016.