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Access relevant and topical news on all things biosimilars from FDA approvals to market trends, available anytime, anywhere.
Who’s leading the biosimilars race?
With the first biosimilar approved in the US, pharmaceutical companies are scrambling to bring the next to market…
Introduction to Biosimilars
With the recent approval of the first biosimilar, get a quick overview of the market and impact the pending…
What Do Doctors Think?
As the global biosimilars market opens up, what do physicians faced with choosing between prescribing a brand-name biologic or biosimilar think – and know?
New FDA guidelines for biosimilar makers
The FDA has published three guidelines to assist product sponsors in demonstrating biosimilarity to a reference product…
Brazil Approves Its First Biosimilar, Remsima
ANVISA, Brazil’s health regulatory body has approved the country’s first biosimilar drug, infliximab, manufactured by Celltrion.
Expert Panel Discusses Biosimilars Impact
Biosimilars regulation, naming and U.S. healthcare impact were among topics discussed at an expert panel hosted by the Alliance for Health Reform on May 20.
What you Need to Know about Biosimilars
Learn the history of biosimilars in the European Union and how they define and regulate biological products…
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BIOSIMILAR BACKGROUND AND BIOLOGIC PROFILES
Learn about biologics and their uses, patent expiration, as well as general background on biosimilars, how they are manufactured and those that have been FDA approved.
Understand the Food and Drug Administration’s process and requirements for approving a biosimilar drug as well as the stringent policies and regulations that are in place for manufacturers.
MARKET TRENDS AND OPPORTUNITIES
Gather information on the market implications of biosimilar products, opportunities and challenges in the market, and the cost benefit analytics of entering the market.
With the approval of the first biosimilar product in the US and more on the horizon, BioLink has helped me to stay up to date and informed on this very important topic.
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