Biosimilars and Biobetters

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.

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).

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

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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

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

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

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.

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

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.

FDA advances the progress of biosimilars 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.

Greater transparency and reliability of information are needed in the quality assessments of biosimilars.

The agency announced it is taking steps to increase competition within the prescription drug market.

The agency recommended approval of treatments for hepatitis C, cancer, multiple sclerosis, and arthritis.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

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

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

The program aims to make biosimilars for the treatment of cancer more widely available in middle- and low-income countries.

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference.