The Center for Biosimilars Staff

December 18, 2018

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

December 17, 2018

Australian drug developer NeuClone has disclosed that it is currently developing a proposed pertuzumab biosimilar referencing Perjeta.

December 14, 2018

In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.

December 12, 2018

Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.

December 10, 2018

With the likelihood increasing that the United Kingdom will leave the European Union without a trade agreement in early 2019, the UK Health Secretary, Matt Hancock, has issued new advice to the pharmaceutical industry in which he warned that there could be long border delays that seriously impact the flow of pharmaceuticals in Europe.

December 09, 2018

Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC.

December 06, 2018

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

December 05, 2018

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.

December 04, 2018

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).

December 03, 2018

On Friday, Pfizer announced that it has signed an agreement with AbbVie that resolves all intellectual property disputes related to Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira.