Manufacturing

Articles

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

FDA Approves Pfizer Biosimilar to J&J’s Remicade

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product. 

FDA Approves Sanofi’s Follow-On Insulin

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Stakeholders Comment on FDA Draft Guidance for Evaluating Biosimilarity

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

FDA Approves First Biosimilar to Roche’s Herceptin

Biocad and Sothema Labs have partnered to release cancer-treating biosimilars into the North African market.

Biocad Announces New Manufacturing Site in North Africa

Merck KGaA completes the divestment of its biosimilars business as part of its strategy to focus on developing a pipeline of innovator drugs.

Merck KGaA Completes $788-Million Divestment of Biosimilars Business

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.


Congress Passes FDA User-Fee Reauthorization Bill

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

FDA Accepts Application for Teva’s Herceptin Biosimilar

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval. 


Supreme Court Rules in Amgen v. Sandoz

Catherine Shaffer is a contributing writer to BioPharm International, cathshaffer@gmail.com.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Manufacturing, Biosimilars and Biobetters