Regulatory

BioRationality: FDA Advice to Biosimilar Developers on Using PD Markers, Avoid Clinical Efficacy Testing

May 1st 2023

By Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, dives into how pharmacodynamic (PD) markers may be better than clinical efficacy testing for predicting whether a biosimilar is equally as safe and effective as its reference product, in his latest column.

Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval

April 26th 2023

By Skylar Jeremias

Article

Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.

Senators Introduce Bill to Establish Insulin Cap for Commercial Plans

April 25th 2023

By Skylar Jeremias

Article

Two US senators introduced a bipartisan bill to extend the $35 out-of-pocket cap for insulin products, established by the Inflation Reduction Act for Medicare plans, to the commercial sector.

FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar

April 14th 2023

By Skylar Jeremias

Article

In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.

EU, Brazil Advance Hematology, Oncology Biosimilars

April 12th 2023

By Skylar Jeremias

Article

The Committee for Medicinal Products for Human Use gave a thumbs up for an eculizumab biosimilar, and a biologic license application for a bevacizumab biosimilar was accepted in Brazil.

Eye on Pharma: EU Approves High-Concentration Adalimumab Biosimilar; FDA Accepts BLA for HLX02

April 6th 2023

By Skylar Jeremias

Article

The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

BioRationality: FDA Changes the BsUFA Meetings Scope—How to Expedite the Regulatory Approval of Biosimilars

April 3rd 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, explains and analyzes the FDA's changes for the Biosimilar User Fee Act (BsUFA) meetings and how they influence the efficiency of the biosimilar approval process in the latest installment of his bimonthly column.

Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy

March 30th 2023

By Skylar Jeremias

Article

Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

The Increasing Access to Biosimilars Act of 2023 Introduced to Congress

March 29th 2023

By Skylar Jeremias

Article

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

Canadian Province Newfoundland and Labrador Adds Biosimilar Switching Policy

March 28th 2023

By Skylar Jeremias

Article

Newfoundland and Labrador is the latest Canadian province to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.