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How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog: Biosimilars

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.

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AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB)

The Pharma Data

. “Amgen remains committed to providing patients who live with inflammatory diseases access to high-quality biosimilar medicines,” said David M. Amgen has a total of 11 biosimilars in its portfolio, including five that have been approved by the U.S. For more information, visit www.amgenbiosimilars.com. Reese, M.D.,

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Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: Biosimilars Are Delivering Higher Profits for Drug Distributors (press release) We’re offering special discounted pricing if you order before October 15, 2021! Section 4.4.

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NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022! We also update sections that were introduced in recent editions, such as our estimates of wholesalers' profits from provider-administered biosimilar drugs.