FDA approves Pfizer's Humira biosimilar, offers update on progress biosimilar approvals

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FDA approves Pfizer's Humira biosimilar, offers update on progress biosimilar approvals

By Sandra Levy - 11/18/2019

Pfizer has received the Food and Drug Administration’s clearance for Abrilada (adalimumab-afzb). The product is a biosimilar to AbbVIe’s Humira (adalimumab).

It is indicated for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” said Richard Blackburn, Pfizer inflammation and immunology global president. “Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients.”

Pfizer is working to make Abrilada available to U.S. patients as soon as feasible based on the terms of its agreement with AbbVie and plans to launch the product in 2023.

In a statement on the FDA's continued progress in facilitating competition in the biologic marketplace, Sarah Yim, acting director of the office of therapeutic biologics and biosimilars in the FDA’s center for drug evaluation and research, said, "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."

Yim added, "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."

Yim continued,"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, or 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. "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," said Yim.



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