Biosimilars and Biobetters

Revamping the Citizen’s Petition Process for FDA

October 02, 2019

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

iBio and South Africa’s AzarGen Advance Development of Biosimilar Rituxan

September 25, 2019

The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.

Celltrion and Lonza Sign Contract to Manufacture Remsima Drug Substance

September 03, 2019

The partnership will provide cost effective biologics for the world market.

Sandoz in Deal to Commercialize Biosimilar Natalizumab

September 03, 2019

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

Alvotech, Prestige Biopharma Form New Manufacturing Partnership

August 30, 2019

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

Biosimilar Teriparatide Launches Across Europe

August 23, 2019

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

Amgen Wins Enbrel Patent Case, Sandoz to Appeal Ruling

August 13, 2019

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

FDA Revamps Biosimilar Quality Requirements

July 02, 2019

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

Proposed Rule Designed to Open Biosimilar Competition

July 02, 2019

FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.

FDA Approves Amgen and Allergan's Biosimilar to Herceptin

June 24, 2019

The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.