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534 News Found

Biogen sells equity stake in its biosimilar JV with Samsung Biologics for US $ 2.3 billion
News | January 28, 2022

Biogen sells equity stake in its biosimilar JV with Samsung Biologics for US $ 2.3 billion

The companies will continue with their exclusive agreements, including commercialization of their current portfolio


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA
Biotech | December 21, 2021

Sandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDA

Trastuzumab is monoclonal antibody used to treat human epidermal growth factor receptor 2 positive (HER2+) breast cancer and metastatic gastric cancers


Dr Reddy’s and Prestige BioPharma collaborate to commercialise trastuzumab biosimilar
Biotech | December 09, 2021

Dr Reddy’s and Prestige BioPharma collaborate to commercialise trastuzumab biosimilar

The license agreement grants Dr. Reddy's the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia


Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts
News | October 21, 2021

Biocon Biologics’ interchangeable biosimilar insulin Glargine preferred on Express Scripts

Express Scripts, a leading pharmacy benefit management organization, will list Viatris labelled biosimilar insulin Glargine as a preferred insulin brand on its National Preferred Formulary (NPF)


FDA approves Cyltezo, the first interchangeable biosimilar to Humira
Drug Approval | October 20, 2021

FDA approves Cyltezo, the first interchangeable biosimilar to Humira

Second interchangeable biosimilar product approved by agency


Zydus Cadila receives final approval for Apremilast
Drug Approval | September 24, 2021

Zydus Cadila receives final approval for Apremilast

Zydus' Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy


Aurobindo subsidiary submits MAA for oncology biosimilar
Biotech | September 23, 2021

Aurobindo subsidiary submits MAA for oncology biosimilar

CuraTeQ Biologics is on track for filing a second oncology biosimilar


U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar
Drug Approval | September 21, 2021

U.S. FDA approves Samsung Bioepis and Biogen’s BYOOVIZ biosimilar

It becomes the first ophthalmology biosimilar to gain FDA approval in the United States


Sandoz enters agreement for oncology biosimilar medicine bevacizumab
Drug Approval | September 09, 2021

Sandoz enters agreement for oncology biosimilar medicine bevacizumab

Sandoz is committed to building on its leading generic and biosimilar oncology portfolio to further expand patient access while contributing to the sustainability of healthcare systems