Biosimilars and Biobetters

The recommended drugs include two orphan medicines and three biosimilars.

In launching FDA’s Biosimilar Action Plan, Gottlieb takes innovator companies to task for delaying competitive biosimilar products.

AbbVie will grant Mylan license to launch a biosimilar to AbbVie’s Humira.

CPhI Korea to feature zone for finished dosage formulation drug products.

Biogen will pay Samsung BioLogics approximately $700 million to increase its stake in Samsung Bioepis to approximately 49.9%.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

Safeguarding the know-how behind biopharmaceutical innovation is crucial to the industry’s future, but, in the US, some argue it is becoming increasingly difficult to do.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.

The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).