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The United States has missed out on almost $20 billion in savings as a result of not having a competitive biosimilar market, according to findings from the Pacific Research Institute.

Report: Lack of Biosimilar Competition Contributed to Billions in Lost Savings

Lotus and CKD Pharmaceutical intend to be among the first to bring a darbepoetin alpha biosimilar to Southeast Asia.

Lotus Inks Deal With CKD to Distribute Darbepoetin Alpha Biosimilar

Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write. 

UK Regulators Contend Biosimilar Efficacy Trials Are Redundant

Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.

Celltrion's COVID-19 Antibody Treatment Moves Into Phase 2/3 Trial

Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.

PrestigePharma Reports Positive PK Data for Bevacizumab Candidate

The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace. 

ACP Calls for Biologics Marketplace Reforms

A broader range of indications in rheumatology combined with a Canadian push for biosimilar acceptance bodes well for Merck's Brenzys product. 

Merck's Etanercept Gains More Indications for Use in Canada

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Rep Grothman Introduces Bill for Automatic Insulin Biosimilar Interchangeablity 

April E. Weisbruch is a partner at McDermott, Will, & Emery LLP. She focuses her practice on intellectual property (IP)  matters, particularly in managing large-scale IP litigation and counseling. She works with clients in wide-ranging technology sectors, including pharmaceuticals, software applications, medical devices, organic chemistry and ballistics. April represents clients in all phases of patent litigation, from the filing of a complaint through appeal, as well as in the highly specialized post-grant proceedings before the United States Patent Trial and Appeal Board (PTAB). She has extensive deposition, hearing and trial experience in US district courts throughout the country, as well as in the US Court of Federal Claims, the US Court of Appeals for the Federal Circuit, and the PTAB. Her litigation experience includes traditional "competitor" litigation, litigation against nonpracticing entities, ANDA litigation under the Hatch-Waxman Act and §1498 litigation against the United States of America.

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

What We Learned About Biologics on Summer Vacation

Trade associations and companies in the biosimilars business ask the FDA to hone its proposed study on product disclosures.

Regulatory