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Analyzing the impact of biosimilars on biologic drug development pipelines

Drug Patent Watch

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. Generic and biosimilar developers benefit from earlier market entry.

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FDA Announces a Return to In-Person Meetings for All PDUFA, BsUFA, and OMUFA Meeting Types

FDA Law Blog: Drug Discovery

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. As reported in this recent Pink Sheet article , FDA staff recently noted that a substantial majority of meeting requests for eligible in-person meeting types have not been requested as such.

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IQVIA vs Vial | Pros and Cons

Vial

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This article provides a comparative overview of Vial and IQVIA.

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Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

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Can Your CRO Add Value During a Recession?

PPD

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

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The National Products Association Challenges FDA’s Interpretation of the Dietary Supplement Exclusionary Clause

FDA Law Blog: Biosimilars

The phrase in subsection (ii) “authorized for investigation as a new drug” is generally accepted to mean that an IND is in effect. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.