Regulatory

Bach, Coauthors Call for Regulated Pricing for Biologics as an Alternative to Biosimilars

April 15th 2019

By Allison Inserro

The 2-part proposal from Peter B. Bach, MD, and 3 coauthors published Monday argues that biosimilar competition is an economically inefficient way to achieve the goal of lower prices.

Diverging from US, Canada Approves Biosimilar Rituximab in Both Oncology and Rheumatology Indications

April 15th 2019

By Kelly Davio

Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Russian Drug Maker Gains World's First Approval for Biosimilar Eculizumab

April 11th 2019

By The Center for Biosimilars Staff

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.

Genentech Sues Pfizer Over Proposed Bevacizumab Biosimilar, PF-06439535

April 9th 2019

By Kelly Davio

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

FDA Finalizes Guidance on When REMS Programs Are Needed

April 5th 2019

By Kelly Davio

The FDA this week finalized a 2016 draft guidance that explains when the agency deems a Risk Evaluation and Mitigation Strategy (REMS) program to be necessary for a given drug.

The Top 5 Biosimilars Articles for the Week of April 1

April 5th 2019

The Center for Biosimilars® recaps the top news for the week of April 1, 2019.

Congressional Diabetes Caucus Looks to Codify FDA's Insulin Transition Guidance

April 4th 2019

By Allison Inserro

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

Celltrion Completes Enrollment of Phase 3 Trial of CT-P17, Gives Update on Subcutaneous CT-P13

April 4th 2019

By Kelly Davio

Korean drug maker Celltrion announced that it has completed enrollment in its phase 3 clinical trial of CT-P17.

Fresenius Kabi Gains European Authorization to Market Adalimumab Biosimilar, Idacio

April 3rd 2019

By Kelly Davio

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

Sandoz Resubmits BLA for Pegfilgrastim Biosimilar

April 3rd 2019

By Kelly Davio

Sandoz announced today that it has resubmitted to the FDA its Biologics License Application (BLA) for its proposed biosimilar pegfilgrastim.