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Addressing supply chain challenges for biosimilar products

Drug Patent Watch

Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

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Osteoporosis treatment options – down to the bare bones

pharmaphorum

ResearchandMarkets also recently published a report , which highlighted only biosimilars as the emerging treatments for osteoporosis. Emerging research and biosimilars. Sandoz recently announced positive clinical trial results from a phase 1/3 into its biosimilar to denosumab.

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COVID-19: Celltrion’s therapeutic option

pharmaphorum

This really tested pharmaceutical companies,” explains Ki-Sung. We found that strong and open channels of communication were imperative. The company remained in close and frequent communication with regulatory agencies to accelerate procedures for the evaluation and authorisation of the clinical trials.

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OPDP Coming Out! New Untitled Letter, Old Issue

FDA Law Blog: Biosimilars

The letter itself is pretty typical of what we would expect to see from OPDP – prioritizing a communication that includes no safety information despite numerous efficacy claims, calling out an efficacy claim as misleading, and failing to submit promotional material on Form 2253. So, what gives?

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Strategies for successful biosimilar-to-biosimilar switching

Drug Patent Watch

The Future of Biosimilars: Switching Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are looking for innovative ways to stay ahead of the competition. One strategy that's gaining traction is biosimilar-to-biosimilar switching.

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Sandoz targets barriers to biosimilar accessibility with latest initiative

Pharmaceutical Technology

Generic and biosimilar pharmaceutical company and Novartis subsidiary Sandoz announced its plan to accelerate patient access to biosimilars. In a 15 June statement, Sandoz said that it hoped the Act4Biosimilars action plan will provide actionable solutions to overcome barriers preventing patient access to biosimilars.

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Primate models in pharma: What the future holds

Pharmaceutical Technology

For example, in 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) published its first comprehensive guideline on biosimilars , which provided clear recommendations onthe requirements for animal and clinical efficacy studies. This approach to more pragmatic regulation is also trending globally.