Regulatory

AAM White Paper Breaks Down Drug Shortage Crisis: Causes and Solutions

July 25th 2023

By Skylar Jeremias

Article

The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.

BioRationality: US Senate Reignites the Push for Biosimilars to Become Interchangeable

July 24th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, details his efforts to encourage congressional leaders to draft legislation that would remove interchangeability requirements and animal toxicology studies for biosimilars.

Senator Reintroduces Biosimilar Red Tape Elimination Act

July 14th 2023

By Skylar Jeremias

Article

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

BioRationality: FDA Calls Meeting to Reevaluate the Need for Clinical Efficacy Testing of Biosimilars

July 10th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, flagged an upcoming FDA meeting where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

Samsung Bioepis' Eculizumab Biosimilar Approved in Europe

May 31st 2023

By Skylar Jeremias

Article

The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.

FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar

May 24th 2023

By Skylar Jeremias

Article

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing

May 15th 2023

By Sarfaraz K. Niazi, PhD

Article

Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.

Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry

May 11th 2023

By Skylar Jeremias

Article

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

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

May 1st 2023

By Sarfaraz K. Niazi, PhD

Article

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.