On January 15, 2020, Hospira filed a petition for rehearing en banc asking the full Federal Circuit to reconsider a prior panel’s analysis of the Safe Harbor provision and reverse the finding of infringement. In December 2019, the Federal Circuit affirmed the District of Delaware’s decision denying Hospira’s motion for judgment as a matter of
FDA
U.S. Biosimilar Launches Accelerate with Five Launches in Q4 2019 and early 2020
- Since November 2019, biosimilar versions of pegfilgrastim, rituximab, bevacizumab, and trastuzumab have launched in the United States.
- FDA approved fifth Humira® (adalimumab) biosimilar, but it will not launch until 2023.
- FDA approved third Neulasta® (pegfilgrastim) biosimilar and all three have launched.
- FDA approved fourth Remicade® (infliximab) biosimilar.
As pharmaceutical drug costs attract increasing media attention…
FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation
- FDA approves fourth Humira® (adalimumab) biosimilar with launch delayed to 2023.
- FDA approves second Rituxan® (rituximab) biosimilar, neither of which has launched.
- FDA approves second Avastin® (bevacizumab) biosimilar, which is expected to launch in late 2019.
- FDA approves fifth Herceptin® (trastuzumab) biosimilar, which launched in July 2019.
- European Medicines Agency has not approved any new
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U.S. – E.U. Mutual Recognition Agreement Will Reduce Costs
The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a mutual recognition agreement (MRA) regarding good manufacturing practice (GMP) inspections in the European Union. Slovakia was the last of the 28 member states of the European Union to be recognized as capable of…
The Federal Circuit Affirms District Court Finding that Sandoz Does Not Infringe Amgen’s Protein Purification Patent
In a recent precedential opinion[1], the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz for its G-CSF biosimilar infringed claims of Amgen’s patent describing a multistep purification procedure for proteins expressed in a non-mammalian system.
In this case, the Federal Circuit explained that the doctrine of…
Another Biosimilar Receives FDA Approval and Is Confronted with Litigation
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by Samsung Bioepis. Eticovo is a biosimilar to Enbrel® (etanercept), which is marketed by Amgen, Inc. (“Amgen”). Like Enbrel, Eticovo was approved across five eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic…
How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
- FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.
- FDA approves the fourth Herceptin® (trastuzumab) biosimilar—no trastuzumab biosimilar has launched in the United States to date.
- European Medicines Agency approves ninth and tenth adalimumab biosimilars and second bevacizumab biosimilar.
As pharmaceutical drug costs attract increasing media attention…
Biologic Patent Transparency Act Addresses High Biologic Prices
Many factors contribute to the price that consumers pay for prescription drugs and biologics. These factors include research and development costs, manufacturing costs, terms negotiated by insurance plans, supply and demand, and intellectual property rights. Intellectual property rights are often viewed as one of the most significant factors driving high drug and biologic prices. In…
Jury Finds Amgen Antibody Patents Not Invalid
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for treatment of high cholesterol.[1] The case reached an important milestone recently as a jury entered a verdict largely upholding the validity of Amgen’s asserted patents, to the disappointment of Sanofi and Regeneron. A similar…
Biosimilars Will Get Special Names- Suffixes Are Here to Stay
On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special names for biosimilar products to distinguish them from previously approved biologic products. Specifically, the guidance explains that:
- The FDA no longer intends to modify the proper names of biological products that have already been
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