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April 05, 2018
The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
March 29, 2018
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
March 08, 2018
The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.
February 01, 2018
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
December 18, 2017
The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.
December 14, 2017
FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.
December 13, 2017
The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.
December 05, 2017
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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
December 04, 2017
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.