Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

FDA Statement

• For Immediate Release: November 15, 2019

Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant cells, and microorganisms such as bacteria or yeast, and developed using advanced science. They are usually more complex than other drugs and are particularly critical in the treatment of cancer and autoimmune conditions, such as rheumatoid arthritis, psoriasis and inflammatory bowel disease.

Historically, biologics lacked effective competition in the marketplace because there was no abbreviated FDA review pathway for bringing “follow-on” versions of biologics to market. That changed when Congress gave FDA the authority to implement an abbreviated approval pathway for biosimilar and interchangeable biological products in 2010. This pathway provides for the agency’s review and approval of biosimilar products, which may offer more access to treatments and lower costs for patients. A biosimilar product is highly similar to, and has no clinically meaningful differences from, an existing FDA-approved biologic product, called the reference product. Our ability to support a market for safe, effective biosimilar products is key for patients and our nation’s health care system. 
 
Today the FDA took another step to further foster biologics competition with the approval of Abrilada (adalimumab - afzb), a biosimilar to Humira. Today’s approval is one of nine new biosimilar products the FDA has taken action on in 2019, bringing the overall total of biosimilar approvals to 25. I’m pleased to see this progress and am confident that the market for these therapies will continue to grow. To date, 74 programs for 38 different reference products have been enrolled in our Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.

Importantly, health care professionals and patients can be confident when using an FDA-approved biosimilar product. Biosimilar products approved by the FDA undergo a rigorous evaluation to determine that they meet the requirements for licensure and are manufactured under the same quality standards as brand name medicines.  

We are also continuing the agency’s work under the Biosimilars Action Plan to improve the efficiency of the biosimilar and interchangeable product development and approval process. This includes efforts to develop and implement new biosimilar-specific review templates and progress towards the development and validation of pharmacodynamic biomarkers tailored to biosimilar development. As outlined in this plan, we’re continuing to provide scientific and regulatory clarity for the biosimilar development community, and at the same time, we are undertaking communication and outreach efforts for educating patients, clinicians and payors about biosimilars’ safety and effectiveness.

Another important part of our work, at Congress’ direction, is facilitating the March 23, 2020, transition of approved marketing applications for biological products regulated under the Federal Food, Drug, and Cosmetic Act to be approved biologics license applications regulated under the Public Health Service Act (PHS Act). This means that these biological products, including products like insulin that are in great demand and have seen price increases, will be regulated under the PHS Act like other biological products and open to biosimilar competition. This, in turn, could lead to the development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness. The FDA held a public hearing on the development of biosimilar and interchangeable insulin products in May, and we are analyzing the comments we received from many different stakeholders, including those who are directly affected by the price of insulin and who would benefit from the impact of additional competition from biosimilar and interchangeable products. Our work in this area continues and is a high priority.

The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.

The FDA granted the approval of Abrilada to Pfizer Inc. Humira was approved in December 2002 and is manufactured by AbbVie Inc. 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.