Biosimilars and Biobetters

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

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

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

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

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

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.

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

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

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

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

Prestige BioPharma has announced that the EMA has accepted its marketing authorization application for HD201 (Tuzune) for review.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.

Novartis’ Sandoz resubmitted its biologics license application (BLA) for a proposed biosimilar pegfilgrastim to FDA in response to a 2016 complete response letter from the agency.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Do patients get what they pay for when they demand cheaper drugs?

C-Bridge Capital will form a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis to accelerate clinical development and registration of Samsung Bioepis’ next-generation biosimilars in China.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.

The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.

The company’s biosimiliar to Roche’s Avastin (bevacizumab) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

FDA has approved Truxima (rituximab-abbs), a biosimilar to Roche’s anti-cancer biologic, Rituxan (rituximab).

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

AbbVie will grant Momenta license to launch a biosimilar to AbbVie’s Humira.

The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).