Business

Federal Circuit Affirms Amgen's Win Against Hospira in Epoetin Alfa Litigation

December 18th 2019

By The Center for Biosimilars Staff

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

Bispecific Antibody Outperforms Adalimumab in Phase 3 Study in Psoriasis

December 17th 2019

By The Center for Biosimilars Staff

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

FDA Analysis Find More Evidence Linking Generic Competition to Lower Prices

December 16th 2019

By Allison Inserro

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

Pfizer's Biosimilar Adalimumab Receives Positive CHMP Opinion

December 16th 2019

By The Center for Biosimilars Staff

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

Outlook Therapeutics Reaches Agreement With FDA on Special Protocol Assessments for ONS-5010

December 14th 2019

By Kelly Davio

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

The Top 5 Biosimilars Articles for the Week of December 9

December 13th 2019

The Center for Biosimilars® recaps the top stories for the week of December 9, 2019.

House of Representatives Passes Pelosi Drug Bill 230-192

December 13th 2019

By Allison Inserro

The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.

AffaMed Gets Chinese Clearance to Start Phase 3 Trial of Biosimilar Trastuzumab, SB3

December 11th 2019

By The Center for Biosimilars Staff

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

Biosimilar Stakeholders Praise Removal of Biologic Exclusivity Provisions From USMCA

December 11th 2019

By Kelly Davio

An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

Sanofi to End R&D on Diabetes, Cardiovascular Drugs

December 11th 2019

By Allison Inserro

Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.