Biosimilars Communication Pharmaceutical Companies 
Drug Patent Watch
MARCH 13, 2025
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.
pharmaphorum
OCTOBER 13, 2022
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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pharmaphorum
JULY 22, 2021
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.
FDA Law Blog: Biosimilars
AUGUST 22, 2023
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?
Drug Patent Watch
FEBRUARY 16, 2025
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.
Pharmaceutical Technology
JUNE 15, 2023
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.
Pharmaceutical Technology
APRIL 12, 2023
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.
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