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Ranibizumab biosimilar by Generium for Wet (Neovascular / Exudative) Macular Degeneration: Likelihood of Approval

Pharmaceutical Technology

Ranibizumab biosimilar is under clinical development by Generium and currently in Phase III for Wet (Neovascular / Exudative) Macular Degeneration. GlobalData’s report assesses how Ranibizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.

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Rituximab biosimilar by Dr. Reddy’s Laboratories for Rheumatoid Arthritis: Likelihood of Approval

Pharmaceutical Technology

Rituximab biosimilar is under clinical development by Dr. Reddy’s Laboratories and currently in Phase III for Rheumatoid Arthritis. According to GlobalData, Phase III drugs for Rheumatoid Arthritis have a 65% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration.

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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

Amgen drug development highlights – November 2023 In November 2023, Phase II trial results for immunotherapy tarlatamab demonstrated an ability to provide sustained anti-tumour activity in 40 percent of the small cell lung cancer trial patients.

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Biopharmaceuticals contributing to manufacturing outsourcing trend

European Pharmaceutical Review

This is due to these companies looking to meet to the varied needs of pharmaceutical developers, according to the authors. Increasing the outsourcing of manufacturing activities is helping pharmaceutical companies to focus on their core capabilities. percent between 2022-2030.

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Is India capable of ensuring equitable access to biopharmaceuticals?

Express Pharma

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

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Digitalisation to boost quality management systems market

European Pharmaceutical Review

FDA publishes paper on AI/ML in drug development In 2022, North America had the largest revenue share in the global pharmaceutical quality management systems market, according to the report. These solutions eliminate the need for on-premise servers and hardware, reducing IT infrastructure costs for pharmaceutical companies.

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ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law Blog: Biosimilars

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.