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BioRationality: A Dr Sarfaraz Niazi Column—FDA Discloses Changes to Drug Review Process, Biosimilar Licensing

January 30, 2023

Sarfaraz K. Niazi, PhD, explains the FDA's changes to the drug review process, the significance of each change, and the published pieces of work that helped inform the FDA's decisions.

Seeing Eye to Eye: FDA's Dr Sarah Yim Discusses Efforts to Increase Confidence in Ophthalmology Biosimilars

January 29, 2023

Phase 3 Trial Suggests Equivalence Between Biosimilar CKD-701 and Reference Ranibizumab in nAMD

January 28, 2023

The Top 5 Biosimilar Articles for the Week of January 23

January 27, 2023

Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy’s Completes Study

January 26, 2023

Featured Content

Global Use of Medicines Report Predicts Biosimilars Will Save $290 Billion by 2027

January 25th 2023

By Skylar Jeremias

Article

IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.

IRA Insulin Cap Could Have Saved Medicare Beneficiaries Millions in 2020

January 24th 2023

By Skylar Jeremias

Article

A new report from HHS has revealed that if the Inflation Reduction Act (IRA) had been implemented in 2020, Medicare Part D beneficiaries could have saved a total of $734 million, averaging out to about $500 per member.

Contributor: The US Biosimilar Market Outlook for 2023

January 24th 2023

By Sophia Z. Humphreys, PharmD, MHA

Article

Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.

Part 1: Samsung Bioepis Executive Shares Developer Perspective on Biosimilar Switching Studies, Clinical Efficacy Testing

January 23rd 2023

By The Center for Biosimilars Staff

Article

As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab Results

January 22nd 2023

By Skylar Jeremias

Article

Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.

Phase 3 Study Finds Bioequivalence Between Celltrion Bevacizumab Biosimilar, Avastin for NSCLC

January 21st 2023

By Skylar Jeremias

Article

Celltrion Healthcare’s candidate bevacizumab biosimilar CT-P16 demonstrated equivalent efficacy, safety, and immunogenicity to Avastin (reference bevacizumab), in a phase 3 clinical trial in patients with non–small cell lung cancer (NSCLC).

The Top 5 Biosimilar Articles for the Week of January 16

January 20th 2023

By Skylar Jeremias

Video

Here are the top 5 biosimilar articles for the week of January 16, 2023.

Legal Experts Provide Updates on Biosimilar Patent Disputes in 2022

January 19th 2023

By Skylar Jeremias

Article

Patent litigators from Fish & Richardson, an intellectual property law firm, regaled audiences during a webinar covering all the big biosimilar regulatory and legal decisions throughout 2022, including updates on patent disputes and antitrust investigations.

Study: Denosumab Biosimilar Looks Promising for Osteoporosis in Phase 3 Trial

January 18th 2023

By Justina Petrullo

Article

Researchers found that a denosumab biosimilar appeared comparably safe and effective to reference drug Prolia.

UK Authorizes New Lucentis Biosimilar, Ximluci

January 17th 2023

By Skylar Jeremias

Article

The United Kingdom has approved STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.