Biosimilars and Biobetters

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.

The company has launched its biosimilar rituximab, Ritucad, for the Indian market.

The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.

The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

FDA/FTC collaborate to end false and misleading statements and discuss the future of biosimilars at March 2020 public workshop on a competitive marketplace for biosimilars.

Industry opportunities are increasing for biosimilars, but companies should pay close attention to delivery device design to facilitate success.

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.

FDA is encouraging alternative insulins and challenging anticompetitive practices.

As the date for transitioning the approval of biologic drug to a new pathway comes closer, FDA publishes a final rule and answers questions on the pathway changes.

FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.

The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.

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.

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 announced it has approved 1171 generic drugs in fiscal year 2019.

New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying risk to reduce costs.

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.

This article reviews FDA’s recent efforts to streamline the biosimilar approval process and address quality concerns with the publication of new guidelines that suggest resources to aid in the biosimilar development and characterization process.

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.