News & Analysis as of

India Prescription Drugs Biosimilars

Axinn, Veltrop & Harkrider LLP

Can an Enhanced India-U.S. Partnership Reduce Drug Supply Chain Issues?

In an effort to enhance collaboration, the Indian Pharmaceutical Alliance (IPA) recently proposed that a more formal preferred partnership between the U.S. and India can not only lower drug prices in the U.S. but can improve...more

Axinn, Veltrop & Harkrider LLP

Will India Replace China in the U.S. Drug Supply Chain?

In a recent opinion piece in Newsweek, Dr. Rahul Tiwari asserts that pharmaceutical companies in India have an opportunity to supplant China's dominant position in producing active pharmaceutical ingredients ("API's") and...more

Goodwin

Enzene Biosciences Announced Romiplostim Approval in India

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Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage...more

Goodwin

Enzene Biosciences Teriparatide Biosimilar Obtains Marketing Authoriation in India

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Enzene Biosciences Ltd., located in Pune, India, has announced that it has obtained marketing authorization from the Drug Controller General of India (DCGI) for its first biosimilar product in India. Enzene’s teriparatide...more

Goodwin

Cadila Pharmaceuticals Launches Rituximab and Bevacizumab Biosimilars

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On July 29, 2020, Cadila Pharmaceuticals announced its launch of Rituximab biosimilar Ritucad for the Indian market. Rituximab is used to treat certain types of blood cancers and rheumatoid arthritis....more

Goodwin

International Biosimilars Market Update

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India-based Cadila Pharmaceuticals announced the launch of its bevacizumab biosimilar for the Indian market under the brand name BEVARO. Bevacizumab is a biosimilar of Genentech’s AVASTIN and is indicated for the treatment of...more

Goodwin

Dr. Reddy’s Laboratories Announces Launch of HERVYCTA (trastuzumab) in India

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Dr. Reddy’s Laboratories Ltd. announced today that it launched HERVYCTA (trastuzumab), a biosimilar of Roche’s HERCEPTIN, in India. According to the press release, HERVYCTA is indicated for the treatment of HER2-positive...more

Goodwin

Hetero and Glenmark Launch Adalimumab Biosimilars in India

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Hetero announced this week the launch in India of its adalimumab biosimilar, marketed under the brand name Mabura. Mabura is a biosimilar of Abbvie’s Humira and is indicated for the treatment of rheumatoid arthritis and other...more

Goodwin

Avastin Biosimilar Launches in India

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Hetero Drugs Ltd. has announced the launch of a biosimilar for Roche’s Avastin® (bevacizumab) in India. Hetero is marketing the drug under the brand name “CizumabTM” as a treatment for metastatic colorectal cancer....more

Goodwin

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

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Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.” ...more

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