Regulatory

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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…

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…

  • 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…

  • 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 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

…

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…

Canada implemented its patent term extension program, the Certificate of Supplementary Protection (CSP) framework, on September 21, 2017.  The CSP regime is beneficial to qualifying pharmaceutical product developers because it can add up to two additional years of patent protection.  Notably, CSP is not as beneficial as other major jurisdictions, which generally allow up to…

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…