Biosimilars: 5 Latest Developments

Biosimilar molecules have gained access to the US market, and providers as well as patients are steadily warming up to the idea of using these products. However, challenges persist with legal disputes, continued lack of understanding, safety and efficacy concerns, and interchangeability regulations that vary at the state level.

Following are some of the recent developments with biosimilars:

1. ODAC meeting for 2 anticancer drugs. The FDA’s Oncology Drug Advisory Committee (ODAC) is scheduled to meet next week to review the biologics licensing applications for 2 proposed anticancer biosimilars, for trastuzumab and for bevacizumab. ABP 215, biosimilar to bevacizumab (Avastin), is being developed by Amgen, while MYL-1401O, a biosimilar to trastuzumab (Herceptin), is being developed by Mylan. Approvals for both these drugs would be a major milestone for oncology biosimilars.

The Biologics User Fee Act (BsUFA) action date for the bevacizumab biosimilar is September 14, 2017, and the BsUFA for the trastuzumab biosimilar is September 3, 2017.

2. Switching studies raise provider optimism. A major concern among physicians, especially rheumatologists, is switching patients to a biosimilar and then back to the original biologic. However, several recent studies have shown that this can be safely achieved. A new single-center prospective cohort study examined the effect of switching patients from infliximab (Remicade) to a biosimilar, CT-P13, and found that the switching was both safe and feasible.

3. Interchangeability remains a concern. Physicians from several organizations have submitted their comments to the FDA on the agency’s draft guidance on biosimilar interchangeability. Concerns including extrapolation of indications, switching, labeling, naming, postmarketing studies, and the engagement of disease experts during the review process.

The regulatory agency has received comments from the Coalition of State Rheumatology Organizations, the American Society of Clinical Oncology, the American Gastroenterological Association, the American Academy of Dermatology Association, and the American Autoimmune Related Diseases Association.

4. Substitution laws now legal in 33 US states. Legislation in 33 US states and Puerto Rico allows pharmacists to substitute biosimilar drugs as a replacement for the original brand-name biologic. Despite state-based variance, most adhere to BIO’s principles, which include final decision-making power in the hands of the prescribing physician and maintaining records of the substitution. You can view an infographic here and an article on substitution here.

5. SCOTUS grants flexibility to biosimilar manufacturers. In June this year, the Supreme Court ruled in the Sandoz v Amgen patent case that granted biosimilar manufacturers the flexibility to market their product without waiting an additional 180 days post product approval. While Sandoz believes this ruling will expedite patient access to life-enhancing treatments, Amgen was disappointed with the decision.

Other supporters of the court’s decision include the pharmacy benefits manager Express Scripts, patient advocacy groups, and health plans.