• FDA and EMA both approve biosimilar versions of Stelara® (ustekinumab), Eylea® (aflibercept) and Prolia® and Xgeva® (denosumab).
  • FDA approves 19 biosimilars in 2024.

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare.  These products are highly similar to an already-approved reference product, offering a more affordable

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers.  These biologic medicines, which are highly similar to existing biological products and are designed to be as effective and safe as the brand name drugs, offer the potential to provide

Patent thickets, particularly those involving pharmaceutical patents, appear to have caught the ire of many U.S. senators. Within the past few weeks, two separate letters have urged action to find ways to prevent issuance of overlapping patents covering a single pharmaceutical product. The letters provide insights into the tools they believe are available to address

  • FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab).
  • FDA also approves its third biosimilar version of Neupogen® (filgrastim).
  • EMA has not approved any new biosimilars in 2022, but has recommended approval of teriparatide biosimilar Sondelbay and the pegfilgrastim biosimilar Stimufend.

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a

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

During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20 billion in 2020.  While none have launched thus far, at least eight adalimumab biosimilars are due to launch by

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 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