Last week, Coherus BioSciences, Inc. (“Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™, an adalimumab biosimilar. YUSIMRY™ is a tumor necrosis factor blocker approved as a subcutaneous formulation. It is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. This is

Updated November 15, 2021

  • FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab).
  • FDA has approved only two biosimilars in 2021 after only approving three in 2020.
  • EMA approves four more Avastin® (bevacizumab) biosimilars, bringing the total number of approved bevacizumab approvals to nine, but also withdraws approval of two of bevacizumab and

On October 15, 2021, the U.S. Food and Drug Administration (“FDA”) approved Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm), the first interchangeable biosimilar to AbbVie’s blockbuster immunosuppressant Humira® (adalimumab).  We previously discussed Boehringer Ingelheim’s Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”).  The

The recently enacted “Purple Book Continuity Act of 2019” went into effect as of June 25, 2021.  The FDA must proactively update the Purple Book information every 30 days with an alphabetical list of licensed biologics, including the date of marketing application approval and the marketing/licensure status.  Additionally, there is now a potentially higher price

Updated March 8, 2021

  • FDA has not approved any biosimilars in 2021 after only approving three in 2020.
  • EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira® (adalimumab) biosimilars, and withdraws approval of an adalimumab biosimilar and a pegfilgrastim biosimilar.
  • Given the increasing number of approved biosimilars in Europe,

On January 28, 2021, Bio-Thera Solutions, Ltd., a biopharmaceutical company based in China, announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to bevacizumab, referencing Genentech’s Avastin®, but excluding indications under orphan drug exclusivity protection.  The FDA has set November 27, 2021,

The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food & Drug Administration (“FDA”) to provide more information to the public about patented biological

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer Ingelheim”) submitted a Citizen Petition requesting a change in the FDA’s interpretation of “strength” of biological products under the Biologics Price Competition and Innovation Act (“BPCIA”).  The Citizen Petition is available on regulations.gov under docket number: FDA-2020-P-2247.  Boehringer Ingelheim seeks an interpretation of “strength” to