#biosimilars — Public Fediverse posts

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

Alvotech reports completion of FDA inspection in Iceland

Alvotech (NASDAQ:ALVO) announced Monday that the U.S. Food and Drug Administration (FDA) has completed a routine cGMP (current…
#Iceland #IS #Europe #Europa #EU #ALVO #Alvotech #BiologicsLicenseApplication #biosimilars #BLAResubmission #cGMPCompliance #FDAInspection #Form483 #iceland #island #ReykjavikFacility
https://www.europesays.com/2982475/

Alvotech reports completion of FDA inspection in Iceland https://www.byteseu.com/2011445/ #ALVO #Alvotech #BiologicsLicenseApplication #Biosimilars #BLAResubmission #CGMPCompliance #FDAInspection #Form483 #Iceland #ReykjavikFacility

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

Alvotech Reports Positive PK Results for AVT80

Alvotech has announced top-line results from a pivotal pharmacokinetic study of AVT80, a proposed biosimilar to Entyvio (vedolizumab). The randomized, double-blind, 3-arm study assessed PK similarity, safety, and immunogenicity in healthy adults after a single 108 mg/0.68 mL subcutaneous injection. The data supports the development of the candidate for patients worldwide.

#Alvotech #biosimilars #biotech #lifescience

Alvotech Secures Global Settlement for Aflibercept Biosimilar

Alvotech reached a settlement to market its biosimilar globally. Entry starts Jan 1, 2026, in the UK and Canada. The EEA and other regions follow May 1, 2026. Japan allows full indications by Nov 1, 2026. Combined with a US Q4 2026 license, the company secures worldwide rights to supply partners, subject to regulatory approval.

#biotech #biosimilars #lifescience #Alvotech

Nearly 70% of cancer patients face financial crises within one year after leaving hospital, highlighting urgent need for support. Hospital K suggests using biosimilars to reduce costs and improve treatment access.

#cancercare #financialcrisis #healthpolicy #access2medicine #unreadyposts #VietnamHealth #SustainableHealthcare #biosimilars #patientrights #VietnamNet

#ungthư #sứckhỏe #chínhsách y tế #khủnghoảngtàichính #dượcphẩmsinhhọc #tiếpcậnđiềutrị #bệnhviệnK #côngbằngy tế #sốngkhỏemạnh #vietn

Samsung Biologics announces spin-off to separate CDMO and biosimilar businesses, aiming to resolve conflicts of interest and secure growth momentum in both sectors.
#YonhapInfomax #SamsungBiologics #CDMO #Biosimilars #CorporateRestructuring #BiotechIndustry #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=64326

Samsung Biologics announces spin-off to resolve CDMO-biosimilar conflicts, aiming to enhance growth potential and investor clarity in both business segments
#YonhapInfomax #SamsungBiologics #CDMO #Biosimilars #CorporateSpinoff #ConflictOfInterest #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=64313

Celltrion sees potential for expanded biosimilar prescriptions following US drug price reduction measures, expecting limited impact on its products and positive opportunities for sales activities.
#YonhapInfomax #Celltrion #Biosimilars #DrugPriceReduction #USHealthcare #PrescriptionDrugs #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=64175

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#BioPharma #PharmaBusiness #RoyedTraining #biopharmaBD

Celltrion Chairman Seo Jung-jin sees US drug price cuts as an opportunity, maintains 5 trillion won sales target, and plans to decide on US factory by year-end.
#YonhapInfomax #Celltrion #DrugPriceCuts #Biosimilars #USTariffs #CDMOFactory #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=63348

Celltrion sees growth opportunities in US drug price reduction executive order, anticipating market expansion through improved distribution structure and direct price negotiations with government.
#YonhapInfomax #Celltrion #DrugPriceReduction #ExecutiveOrder #Biosimilars #MarketExpansion #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=63004

Celltrion reports Q1 operating profit surge of 868% to 149.4 billion won, driven by strong sales of follow-up products and improved cost efficiency post-merger
#YonhapInfomax #Celltrion #Q1Earnings #OperatingProfit #Biosimilars #PharmaceuticalIndustry #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=62540

Nomura maintains positive outlook on Samsung Biologics, citing potential 31% stock price increase driven by CMO growth, biosimilar sales, and U.S. Biosecurity Act benefits
#YonhapInfomax #SamsungBiologics #Nomura #CMOBusiness #Biosimilars #USBiosecurityAct #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=60169

Samsung Biologics reports Q1 operating profit of 486.6 billion won, up 119% YoY, exceeding market expectations due to expanded production and strong biosimilar sales
#YonhapInfomax #SamsungBiologics #Q1Earnings #OperatingProfit #Biosimilars #ProductionCapacity #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=59963

Celltrion re-elects founder Seo Jung-jin as internal director, highlighting his role in driving innovation and growth in the pharmaceutical industry
#YonhapInfomax #Celltrion #SeoJungJin #InternalDirector #PharmaceuticalIndustry #Biosimilars #Economics #FinancialMarkets #Banking #Securities #Bonds #StockMarket
https://en.infomaxai.com/news/articleView.html?idxno=55540

AbbVie's tight grip on Humira market raises concerns about biosimilars—As biotech recovers, venture firms’ preferences appear to shift — Boehringer, Zealand heat up MASH race with strong phase II data—http://bit.ly/w28kSd #abbvie #humira #biosimilars #funding #mash #nash #boehringeringelheim #ipos #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

J&J narrowly misses Q1 revenue on lower-than-expected Stelara sales—Humira biosimilar scripts take off—Intra-Cellular launches 26% to record high, breaking out after depression drug scores big--http://bit.ly/w28kSd #earnings #jnj #abbvie #humira #biosimilars #depression #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

J&J narrowly misses Q1 revenue on lower-than-expected Stelara sales—Humira biosimilar scripts take off—Intra-Cellular launches 26% to record high, breaking out after depression drug scores big--http://bit.ly/w28kSd #earnings #jnj #abbvie #humira #biosimilars #depression #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

J&J narrowly misses Q1 revenue on lower-than-expected Stelara sales—Humira biosimilar scripts take off—Intra-Cellular launches 26% to record high, breaking out after depression drug scores big--http://bit.ly/w28kSd #earnings #jnj #abbvie #humira #biosimilars #depression #clinicaltrials #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

A group of managed care organizations is examining the value of real world data from Europe and the U.S. to help FDA review alternative biologic drugs.

https://sciencebusiness.technewslit.com/?p=45310

#News #Press #Science #Business #Biologics #Biosimilars #Pharmaceuticals #FDA #Regulations #Grant #RealWorldData #HealthRecords #InsuranceClaims #ManagedCare #DataScience