Regulatory

Innovator Drug Developers Gain New Indications in Bids to Mitigate Biosimilar Impact

October 26th 2019

By The Center for Biosimilars Staff

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

WHO and IGBA Sign Agreement to Promote Biosimilars and Generics

October 23rd 2019

By The Center for Biosimilars Staff

The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.

Mundipharma Receives Positive CHMP Opinion for Pegfilgrastim Biosimilar

October 18th 2019

By Kelly Davio

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

The Top 5 Biosimilars Articles for the Week of October 14, 2019

October 18th 2019

The Center for Biosimilars® recaps the top stories for the week of October 14, 2019.

Belgian Competition Authority Investigating Practices Aimed at Blocking Biosimilars

October 17th 2019

By The Center for Biosimilars Staff

The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines."

Have FDA Actions to Ease Generic Drug Shortages Taken Effect Yet?

October 16th 2019

By Allison Inserro

Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.

California Governor Signs Law Barring Pay-for-Delay Agreements

October 11th 2019

By Allison Inserro

The bill prohibits these agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company. The bill would make violating these provisions punishable by civil penalty.

The Top 5 Biosimilars Articles for the Week of October 7

October 11th 2019

The Center for Biosimilars® recaps the top stories for the week of October 7, 2019.

New Anti-VEGF Agent, Brolucizumab, Cleared by FDA to Treat AMD

October 8th 2019

By Kelly Davio

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.

FDA Rejects Tanvex's Proposed Filgrastim Biosimilar, TX01

October 8th 2019

By Kelly Davio

The FDA has issued a complete response letter for Tanvex BioPharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen.