As we close out another year of global biosimilar successes and twists and turns, it’s always important to take stock on just how far we have come and where we still hope to go as an industry. As in years past, I reached out to members of Biosimilar Development’s editorial board and several other experts to get their take on the past year's progress.
The clock is ticking for state lawmakers to preserve an existing law that allows for prescription drug coupon usage in Massachusetts with an end-of-the-year deadline fast approaching.
Learn the statutory and regulatory requirements for interchangeability designation, how the designation hampers follow-on biologics, and why the FDA should loosen requirements for the designation.
In this article, we review the penetration of biosimilars in the top five EU markets, with special emphasis on the years 2016 and 2018, as well as the key elements that could explain these results. The survey focuses on 23 of the 57 approved products for which we have data from at least 18 months in the five markets.
The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.
Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.
Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?
In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.
An organized effort across biopharma, including drug substance manufacturers and suppliers, is needed to address and meet the needs of industry regarding raw material quality and consistency.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
This white paper presents fundamentals about analytical SEC and describes how our new-generation agarose-based SEC columns are used in analysis of biomolecules.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This free collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.More Content Collections