In this free webinar, gain insight into the evolving global regulatory landscape for biosimilar approval, labelling and pharmacovigilance requirements. Attendees will learn how to design scalable ...
The challenges of complying with payer mandates in biosimilars were discussed in a webinar sponsored by The American Journal of Managed Care® and The Center for Biosimilars®. Several trastuzumab ...
More biosimilars are hitting the US market, but marketplace dynamics have made it difficult to take advantage of these therapies. A panel of leading experts on oncology practice and payment discussed ...
FDA evaluates biosimilarity on a product-by-product basis considering the “totality of the evidence.” In addition to the five statutory biosimilarity requirements above, FDA has provided informative ...
The release of a recent EMA reflection paper, aligning with FDA and WHO positions, has resulted in a renewed focus on the central role of pharmacokinetic (PK) data, the primary status of analytical ...
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Biologic drugs — used to treat diseases such as rheumatoid arthritis and cancer — accounted for 70 percent of the growth in U.S. prescription drug spending from 2010 to 2015. Policymakers in ...
Not surprisingly, there are a lot of questions these days about biosimilars — nearly identical variants of biologic drugs that are expected to achieve the same results in patients as the original ...
BURLINGTON, Mass.--(BUSINESS WIRE)--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that in 2020, biosimilar versions of ...
French Physicians are the Most Conservative When Asked About Indication Extrapolation, According to New Research from Decision Resources BURLINGTON, Mass.--(BUSINESS WIRE)--Decision Resources, one of ...
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