Regulatory

The Top 5 Biosimilars Articles for the Week of December 16

December 20th 2019

The Center for Biosimilars® recaps the top stories for the week of December 16, 2019.

WHO Prequalifies Samsung Bioepis' Biosimilar Trastuzumab

December 20th 2019

By Kelly Davio

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

House Spending Bill Contains a Provision to Treat Chemically Synthesized Polypeptide Products as Biologics

December 18th 2019

By Kelly Davio

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

FDA Analysis Find More Evidence Linking Generic Competition to Lower Prices

December 16th 2019

By Allison Inserro

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

Pfizer's Biosimilar Adalimumab Receives Positive CHMP Opinion

December 16th 2019

By The Center for Biosimilars Staff

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

Hahn Confirmed by Senate to Lead FDA, but Where Does He Stand on Biosimilars?

December 13th 2019

By Kelly Davio

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

FDA Approves Amgen's Infliximab Biosimilar, Avsola

December 6th 2019

By Kelly Davio

The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.

The Top 5 Biosimilars Articles for the Week of December 2

December 6th 2019

The Center for Biosimilars® recaps the top stories for the week of December 2, 2019.

The Top 5 Biosimilars Articles for the Week of November 25

November 29th 2019

The Center for Biosimilars® recaps the top stories for the week of November 25, 2019.

Approval of sBLA for Mylan and Biocon's Biosimilar Pegfilgrastim Will Allow for Scale-up, Companies Say

November 27th 2019

By Kelly Davio

Biocon announced today that its supplemental Biologics License Application (sBLA) for its biosimilar pegfilgrastim, Fulphila, filed with partner Mylan, has been approved by the FDA.