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

  • 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

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

  • Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States.
  • Pfizer launches Retacrit®, an epoetin alfa biosimilar, in the United States.
  • FDA approves the first rituximab biosimilar, although it has not yet launched in the United States.
  • European Medicines Agency approves third, fourth, and fifth pegfilgrastim biosimilars and a fifth trastuzumab biosimilar, while

  • European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar
  • Pfizer launches NivestymTM, a filgrastim biosimilar, in the United States
  • Only five of twelve approved biosimilars have launched in the United States

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

  • FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)
  • European Medicines Agency approves third and fourth trastuzumab, fourth infliximab, and fifth, sixth and seventh adalimumab biosimilars
  • Only four of twelve approved biosimilars have launched in the United States

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

  • European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars
  • FDA has not approved any biosimilar drug in 2018
  • Only three of nine approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S.

  • U.S. Food & Drug Administration and European Medicines Agency approve first trastuzumab biosimilars
  • U.S. Food & Drug Administration approves a second infliximab biosimilar

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years.  Global sales