#biosimilars — Public Fediverse posts

We reposting an article of Monday about post-marketing surveillance for biosimilars.

#Biosimilars #Pharmacovigilance #ClinicalResearch #RealWorldEvidence #CDSCO #Pharma #CRO #ClinicalTrials

https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html

Biosimilar approval is not the finish line.
It's the point at which your pre-approval dataset — intentionally smaller than a novel biologic — meets real patients, real clinical practice, and real immune systems.

PMS isn't overhead. It's the second half of your evidence strategy.

#Biosimilars #Pharmacovigilance #ClinicalResearch #Pharma #CRO #CDSCO #ClinicalTrials #genelife

https://genelifecr.blogspot.com/2026/05/post-marketing-surveillance-for.html

Formycon to report 2025 results April 22 and boost investor outreach with major conferences in Q2 2026, including Jefferies Healthcare and UBS Life Sciences events. #Biosimilars #Pharma

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

𝗖𝗮𝗻 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 𝗺𝗮𝗸𝗲 𝗮𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 𝗺𝗼𝗿𝗲 𝗮𝗳𝗳𝗼𝗿𝗱𝗮𝗯𝗹𝗲?
Governments like South Korea are introducing pricing caps on 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀, 𝗶𝗺𝗽𝗿𝗼𝘃𝗶𝗻𝗴 𝗮𝗰𝗰𝗲𝘀𝘀𝗶𝗯𝗶𝗹𝗶𝘁𝘆 𝗮𝗻𝗱 𝗯𝗼𝗼𝘀𝘁𝗶𝗻𝗴 𝗮𝗱𝗼𝗽𝘁𝗶𝗼𝗻 across APAC.
𝗥𝗲𝗮𝗱 𝗺𝗼𝗿𝗲: https://www.kenresearch.com/industry-reports/asia-pacific-biopharmaceuticals-market?utm_source=Mastadon&utm_medium=Social&utm_campaign=Aniket

#Biosimilars #HealthcareAccess #PharmaPolicy #APAC

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 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

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

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

AstraZeneca to pay Pfizer $107.5M in damages in Tagrisso patent tussle—FDA approves two biosimilars to blockbuster eye drug Eylea —Why AlphaFold 3 is stirring up so much buzz in pharma --http://bit.ly/w28kSd #astrazeneca #pfizer #patents #legal #biosimilars #fda #eylea #ai #googledeepmind #drugdevelopment #pharma #pharmanews #biotech #biopharma #biotechnology #cafepharma

R to @EMA_News: In 2023, we approved 8 #biosimilars for a wide range of diseases, including a rare genetic disease, #cancers, #multiplesclerosis.

The total of 9⃣7⃣ biosimilars that can be marketed in 🇪🇺 make treatments more accessible and can improve the quality of life for more #patients.

🐦🔗: https://nitter.cz/EMA_News/status/1747252697924006358#m

[2024-01-16 13:41 UTC]

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

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

All approved #biosimilars in the 🇪🇺 are interchangeable 💊.

But it is important that #patients and healthcare professionals carefully read the product information before interchanging a biosimilar treatment.

https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview

Learn more in this video ⬇️

🐦🔗: https://n.respublicae.eu/EMA_News/status/1654381412362117121

Making an informed decision: the key questions to ask when considering a biosimilar

#biosimilars #patientcare #medicationoptions #costeffectiveness

Tim de Gavre is vice president and chief commercial officer, Sandoz.

https://youtube.com/shorts/rObtgyEhcIs

Listen here: https://kevinmd.com/podcast

The power of biosimilars: the benefits of FDA-approved biologics

#biosimilars #FDAapproval #patientcare #medicationoptions

Tim de Gavre is vice president and chief commercial officer, Sandoz.

https://youtube.com/shorts/ymuhXcxsp9c

Listen here: https://kevinmd.com/podcast

Thanks To Evergreening And Legal Threats, AbbVie Has Earned $114 Billion Since 2016 From A Drug Whose Key Patent Expired Back Then

https://www.techdirt.com/2023/02/10/thanks-to-evergreening-and-legal-threats-abbvie-has-earned-114-billion-since-2016-from-a-drug-whose-key-patent-expired-back-then/

#evergreening #biosimilars #drugpatents #monopolies #arthritis #mckinsey #patents #abbvie #humira

Humira #biosimilars set the stage for long-awaited 2023 US launches - Pharmaceutical Technology

https://www.pharmaceutical-technology.com/features/humira-biosimilars-set-the-stage-for-long-awaited-2023-us-launches/ “There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Others are made by big pharma giants like Boehringer Ingelheim, Novartis, or Pfizer, which has raised the expectations for a competitive market. “ #pharma