Biosimilars and Biobetters

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).

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.

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.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

Gottlieb promoted the development of biosimilars and safer opioid packaging at a briefing sponsored by Alliance for a Stronger FDA and the Pew Charitable Trusts.

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

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.

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

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

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

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

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.

The debate continues over biosimilar naming, interchangeability, and patent protection, as well as lingering concerns in the medical community about the safety of switching patients to new therapies.

Reliable, high-quality products require innovative analytics and production.

Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines.

The agency has published educational material for physicians promoting the benefits of biosimilars.

Amgen will collaborate with China’s Simcere Pharmaceutical Group, a R&D-driven pharmaceutical company, to co-develop four biosimilars for the Chinese market.

Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.

The approval marks the first biosimilar approved in the United States for treating cancers.

European Medicines Agency’s Committee for Medicinal Products for Human Use grants a positive opinion for the approval of the biosimilar for treating breast cancer.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

The author outlines an analytical strategy for establishing similarity in biosimilar development and approval.

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

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

Method choice is crucial to when seeking answers to biosimilar characterization questions.

Drug sales forecasts fall for first time in 10 years, thanks to pressures to reduce drug prices and the advent of biosimilars.