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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. link] KBDNA. 2024, May 17). link] Lawless, L.

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

Drug Patent Watch

It allows us to make more informed decisions and identify opportunities that may have been overlooked using traditional methods.” Conducting Due Diligence Once potential targets are identified, thorough due diligence is crucial to validate the assessment and make informed in-licensing decisions.

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes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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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.”

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PreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information

FDA Law Blog: Biosimilars

Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A 513(g) Request for Information is a means of obtaining FDA’s views about the classification and regulatory requirements for a particular device.

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To List or Not to List; That is the Question – The FTC Signals the Potential for Greater Scrutiny of Patent Information Submissions to FDA

FDA Law Blog: Biosimilars

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. The bill proposes to amend FDC Act § 505(b) and PHS Act § 351(a)(2) with respect to patent information submitted to FDA for Orange Book and Purple Book listing. Koblitz & Kurt R.

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FDA Tells Congress What It Wants, What it Really Really Wants (it really really really wants a zigazig-ah)

FDA Law Blog: Biosimilars

In the first category, FDA asks Congress to amend the FDCA to require drug manufacturers to disclose full information about the name and quantity of inactive ingredients in product labeling and permit FDA to disclose to generic sponsors the names and amounts of such inactive ingredients.

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