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February 06, 2020
The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.
January 23, 2020
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.
January 02, 2020
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.
November 20, 2019
The agency’s approval of Abrilada (adalimumab-afzb), a biosimilar to Humira, brings the total of approved biosimilars to 25.
November 12, 2019
Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.
October 02, 2019
The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.
September 25, 2019
The companies have advanced their collaboration to the next stage and will continue to develop a plant-based biosimilar candidate to Roche’s Rituxan.
September 03, 2019
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.