News & Analysis as of

India Prescription Drugs

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

Goodwin on

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

Goodwin on

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

Goodwin on

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

Goodwin on

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

Morgan Lewis

Important Clarifications in the Federal Circuit Acetris Decision

Morgan Lewis on

In addition to standing behind the plain language of the definition of a “US-made end product,” the court in Acetris Health, LLC v. United States provided new guidance regarding limits on Customs and Border Protection...more

Pillsbury Winthrop Shaw Pittman LLP

Substantial Transformation of the FAR Trade Agreements Clause

The Court found the disqualification of an offeror from a pharmaceutical procurement was in error based on a U.S. Customs and Boarder Protection (CBP) interpretation of the Trade Agreements Act of 1979 (TAA)....more

Hogan Lovells

Federal Circuit Acetris Decision Changes Procurement Country of Origin Landscape

Hogan Lovells on

On Monday, in the much-anticipated decision in Acetris Health, LLC v. U.S. 18-2399, the Court of Appeals for the Federal Circuit (the “Federal Circuit”) ruled that U.S. manufacture of a drug is sufficient to confer U.S....more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Revolutionizes Country of Origin Analysis for Pharmaceuticals

The Federal Circuit Court of Appeals has just rejected the longstanding U.S. government position that the country of origin of pharmaceuticals in the context of U.S. government procurement is determined by where the active...more

Smart & Biggar

Rx IP Update - March 2019

Smart & Biggar on

Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more

Goodwin

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

Goodwin on

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

Goodwin on

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

BIOCAD Announces Impending Approval of its Rituximab Biosimilar in India

Goodwin on

On July 4, 2017, BIOCAD, a Russia biotechnology company, announced that in August 2017, it expects to receive permanent market authorization in India for Acellbia, its rituximab biosimilar. BIOCAD reports that its first...more

Polsinelli

USTR Report Highlights Foreign Barriers to U.S. Exports

Polsinelli on

U.S. companies should review a recent USTR (United States Trade Representative) report providing insight into the various country-specific issues that may take center stage in future trade negotiations. Companies should then...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Goodwin

Avastin Biosimilar Launches in India

Goodwin on

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

Goodwin on

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

18 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide