Business

GAO Report on Medicare Part D Finds PBMs Earned Little Revenue From Spread Pricing

August 16th 2019

By Allison Inserro

With rising concern over rising drug prices, policymakers have sought a better understanding of the roles of pharmacy benefit managers (PBMs) in the drug supply chain and plans' and PBMs' efforts to manage Part D drug spending and use.

Samsung Bioepis Begins Recruiting Patients for Phase 3 Trial of Eculizumab Biosimilar, SB12

August 16th 2019

By Kelly Davio

Samsung Bioepis has begun recruiting patients with paroxysmal nocturnal hemoglobinuria (PNH) in India for a phase 3 clinical study of its proposed eculizumab biosimilar, SB12, referencing Soliris.

The Top 5 Biosimilars Articles for the Week of August 12

August 16th 2019

The Center for Biosimilars® recaps the top stories for the week of August 12, 2019.

UnitedHealthcare Will Prefer Amgen's Anticancer Biosimilars Beginning in October

August 15th 2019

By Kelly Davio

In its August 2019 network bulletin, UnitedHealthcare indicated that, beginning October 1, 2019, biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti), both made by Amgen, will be preferred products for commercial and community plans.

Bio-Thera Begins Phase 1 Study of Proposed Golimumab Biosimilar

August 14th 2019

By The Center for Biosimilars Staff

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

Eye on Pharma: FDA Gives Green Light to Aflibercept in Prefilled Syringe

August 14th 2019

By The Center for Biosimilars Staff

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

Canada Announces Reforms to Reduce Prices on Patented Drugs

August 12th 2019

By Kelly Davio

The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.

In Long-Awaited Decision in Etanercept Litigation, Court Sides With Amgen Over Sandoz

August 12th 2019

By Kelly Davio

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.

Court Won't Block Amgen's Biosimilar Sales Despite Genentech's Appeal

August 9th 2019

By Kelly Davio

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

The Top 5 Biosimilars Articles for the Week of August 5

August 9th 2019

The Center for Biosimilars® recaps the top stories for the week of August 5, 2019.