India's biosimilar regulatory framework has changed more in the last decade than most development teams realize.

Phase III trials — once mandatory — can now be waived under the right scientific conditions. Indication extrapolation is now explicitly permitted. Animal studies are no longer routine. And analytical similarity has moved from a supporting role to the foundation of the entire development strategy.

#Biosimilars #ClinicalResearch #RegulatoryStrategy #CDSCO #Biologics #Pharma #CRO

We published an article on Monday about India's biosimilar regulatory framework.

We are reposting the article again, in case you missed that:

#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

Our latest article explores the changing regulatory framework for biosimilars in India.

As the industry moves toward a more science-driven and risk-based approach, understanding the evolving biosimilar ecosystem becomes increasingly important for sponsors, researchers, and healthcare stakeholders.

#Biosimilars #ClinicalResearch #CRO #Pharma #Biologics #DrugDevelopment #CDSCO #RegulatoryAffairs #Pharmacovigilance #RWE

https://genelifecr.blogspot.com/2026/05/biosimilar-regulation-in-india-evolving.html

... general strike by the company's union. [YONHAP]. Samsung Biologics and its union agreed to continue talks after a meeting last Friday failed to ...

Samsung Biologics and its union agreed to continue talks after a meeting last Friday failed to produce an agreement, with escalating legal disputes and starkly different positions on wages and collective bargaining signaling a prolonged standoff.#samsungbio #biologics #strike #union #wage #libranet.de/search?tag=
Samsung Biologics, union to continue talks as work-to-rule persists

🚨 Reframing Veterinary Vaccine Quality Control: A Needed Shift

Traditional veterinary vaccine quality control has long relied on animal-based potency and challenge assays—methods once considered the gold standard.
But today, the field is evolving.
In our recent publication: https://www.researchgate.net/publication/403013746_Reframing_Veterinary_Vaccine_Quality_Control_Integrating_Alternative_Assays_within_Lifecycle-Based_Regulatory_Frameworks

#VeterinaryVaccines #VaccineQuality #3Rs #AnimalFreeTesting #InVitroAssays #VaccineDevelopment #OneHealth #Biologics #InnovationInScience #Biotechnology #EvidenceBased #GlobalHealth

🚨 Reframing Veterinary Vaccine Quality Control: A Needed Shift

Traditional veterinary vaccine quality control has long relied on animal-based potency and challenge assays—methods once considered the gold standard.
But today, the field is evolving.
In our recent publication: https://www.researchgate.net/publication/403013746_Reframing_Veterinary_Vaccine_Quality_Control_Integrating_Alternative_Assays_within_Lifecycle-Based_Regulatory_Frameworks

#VeterinaryVaccines #VaccineQuality #3Rs #AnimalFreeTesting #InVitroAssays #VaccineDevelopment #OneHealth #Biologics #InnovationInScience #Biotechnology #EvidenceBased #GlobalHealth

𝗜𝘀 𝗔𝗣𝗔𝗖 𝗯𝗲𝗰𝗼𝗺𝗶𝗻𝗴 𝗮 $𝟰𝟰 𝗯𝗶𝗹𝗹𝗶𝗼𝗻 𝗯𝗶𝗼𝗽𝗵𝗮𝗿𝗺𝗮 𝗽𝗼𝘄𝗲𝗿𝗵𝗼𝘂𝘀𝗲?
The market is 𝘃𝗮𝗹𝘂𝗲𝗱 𝗮𝘁 ~𝗨𝗦𝗗 𝟰𝟰 𝗯𝗶𝗹𝗹𝗶𝗼𝗻, driven by rising demand for 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀, 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀, 𝗮𝗻𝗱 𝘁𝗮𝗿𝗴𝗲𝘁𝗲𝗱 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 across healthcare systems.
𝗥𝗲𝗮𝗱 𝗺𝗼𝗿𝗲: https://www.kenresearch.com/industry-reports/asia-pacific-biopharmaceuticals-market?utm_source=Mastadon&utm_medium=Social&utm_campaign=Aniket

#Biopharma #APACHealthcare #Biologics #PharmaGrowth

#KNCVMCCB2026 comes to an end with an interesting talk by Danielle Vugts. She talked about the importance of #imaging during #DrugDevelopment on the example of PET imaging of #biologics.

https://link.springer.com/article/10.1186/s41181-024-00258-y
#DrugDiscovery #PETImaging #Radiolabeling #Antibodies #Nanoparticles #Chemistry