Biosimilars: 5 Latest Developments
Biosimilar molecules have gained access to the US market, and providers and patients are steadily warming up to the idea of using these products, but challenges still exist. Here are 5 of the recent developments in the biosimilar landscape.
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
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
3. Interchangeability remains a concern. Physicians from several organizations have
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
5. SCOTUS grants flexibility to biosimilar manufacturers. In June this year, the Supreme Court ruled in the Sandoz v Amgen patent case that
Other supporters of the court’s decision include the pharmacy benefits manager Express Scripts, patient advocacy groups, and health plans.
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