On November 20, 2020, the U.S. Food & Drug Administration (“FDA”) released a Q&A-format draft guidance to address four questions regarding the submission of biologics license applications (BLAs) and labeling for interchangeable biosimilar products. 85 FR 74345 (“Draft Guidance”). The Q&As in the Draft Guidance will be finalized by adding them as a revision to

On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Genentech, Inc. product Lucentis® (ranibizumab).  Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are

The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.[1],[2],[3]  The treatment costs for patients administered biologic drugs are very high relative to historic drug prices.  The one year

The Federal Circuit recently held[1] in a 2-1 decision that there was substantial evidence supporting a jury finding that Teva was liable for induced infringement for an indication carved out of its skinny label for its generic version of carvedilol.

The case concerned GSK’s United States Patent No. 4,503,067 (“the ’067 patent”) and Reissue

Updated October 12, 2020

  • FDA has only approved two biosimilars in 2020.
  • No biosimilars have launched in the U.S. since April 2020.
  • EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin® (trastuzumab) biosimilars.

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs

Last week, the Federal Circuit denied Sandoz’s petition for an en banc rehearing of its precedential July 1st panel decision upholding two of Immunex’s patents covering Enbrel®.

As explained in the petition, Immunex was the first to make etanercept, the tumor necrosis factor (TNF) receptor fusion protein that is the active ingredient in Enbrel® (used

The FDA approved Eli Lilly’s Lyumjev™ (insulin lispro-aabc injection, 100 units/mL and 200 units/mL) last month, which is a new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.  The approval was based on two phase 3 clinical trials based on comparison of Lyumjev and Humalog (insulin lispro

As previously reported, the FDA had yet to approve any biosimilars in 2020 as of June 9, despite a growing pipeline. Since then, the FDA has approved two biosimilar products.

On June 11, Pfizer Inc. announced the FDA’s approval of Nyvepria™ (pegfilgrastim-apgf), a biosimilar of Amgen’s Neulasta™. Nyvepria is indicated “to decrease the incidence of

  • FDA has not approved any biosimilars in 2020.
  • Two Herceptin® (trastuzumab) biosimilars launch in the U.S. in Q1 2020.
  • EMA approves third Enbrel® (etanercept), eleventh Humira® (adalimumab), seventh Rituxan® (rituximab), and second Humalog® (insulin lispro) biosimilars.
  • FDA has redefined “Biologic Products” to open new pathways for biosimilar and interchangeable approvals of proteins including insulin.

As

In February, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) published a joint statement regarding collaborative efforts to promote competition in the marketplace for biological products – including biosimilars and interchangeable products – by identifying joint goals both agencies will work to achieve, as well as measures to be taken