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

Drug Patent Watch

Branded drugs, developed through extensive research and clinical trials, often enjoy patent protection for a limited period. Drugs that require extensive clinical trials for generic approval or fall under special regulatory pathways may have a lower risk of generic entry.

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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law Blog: Biosimilars

LYTGOBI was granted accelerated approval for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 gene fusions or rearrangements. As a single-arm trial (i.e., Join us as we break down what went wrong this time. What Happened?

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The MAHA Assessment’s Implications: Drugs (Part One)

FDA Law Blog: Biosimilars

As stated, the primary focus of the Assessment is on chronic diseases, encompassing both their causes and their treatments. Indications for chronic diseases do not generally reflect the length of the clinical trial; FDA determines that clinical trials supporting such approvals are of sufficient duration and makes an approval determination.

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Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

Millions of people around the world each year face serious illness, with the promise of groundbreaking treatment being just out of reach. We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs.

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

As healthcare professionals, it’s our responsibility to educate patients about generic drugs and empower them to make informed decisions about their treatment options. Trial Periods Offer patients a trial period with the generic drug, assuring them that they can switch back to the brand-name medication if they experience any issues.

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Biosimilar clinical trials and study designs’ considerations

ProRelix Research

Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases.

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The Competitive Edge of Biosimilars

DrugBank

Biosimilars  Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.