News

Sarfaraz K. Niazi, PhD, goes over some misconceptions surrounding biosimilar adoption as well as some national efforts to make biosimilar uptake easier and biosimilar development more economically efficient.

Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, foreshadows how the US market introduction of adalimumab biosimilars could influence future biosimilar entrances and discusses why educational efforts need to be tailored to different specialties and stakeholders.

The proposed omalizumab biosimilar KA (Shanghai Taiyin Biotechnology) demonstrated similar analytical characteristics, in vitro biological activity, and pharmacology and toxicology in animals compared with the originator (Xolair), according to investigators.

The first phase 4 postmarketing surveillance study for SB4 in South Korea as the first approved biosimilar of etanercept demonstrated comparable effectiveness and safety to previous SB4 evidence.

Here are the top 5 biosimilar articles for the week of February 6, 2023.

IQVIA’s Biosimilars in the United States 2023-2027 report found that while the US biologics market has grown 12.5% annually over the last 5 years, spending on biosimilars is growing and is expected to reach $129 billion by 2027.

Formycon shared positive data on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.

Vizient’s Pharmacy Market Outlook report examined the impact that factors, such as the COVID-19 pandemic and the US market introduction of adalimumab biosimilars, will have on drug prices and the utilization of lower-cost biologics.

Sandoz announced that the FDA has accepted the company’s biologics license application (BLA) for its denosumab biosimilar candidate for review.

On this episode of Not So Different, we reminisce about the major biosimilar news to come out of the rheumatology field during January 2023, including the launch of the first Humira (adalimumab) biosimilar.

A real-world study assessing the aftermath of Denmark implementing a nationwide mandatory switch from one infliximab to another found strong treatment retention rates, demonstrating the safety and tolerability of biosimilar-to-biosimilar switching.

Here are the top 5 biosimilar articles for the week of January 30, 2023.

The FDA published its research roadmap as part of the Biosimilars User Fee Act III regulatory research pilot program. The roadmap will allow stakeholders to see how the program will help the FDA enhance regulatory decision-making surrounding biosimilar development.

This year started off with a bang for rheumatology biosimilars, with several regulatory approvals around the world, new market insight into the global use of biosimilars, and US market introduction of the first rival biosimilar to Humira (adalimumab).

Amgen’s Amjevita (adalimumab-atto) has officially entered the US market, making it the first of potentially 10 biosimilars referencing Humira to launch in 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.

On this episode of Not So Different, the FDA’s Sarah Yim, MD, discusses how the FDA is working to improve public trust in ophthalmology biosimilars and interchangeable products as part of a 3-part multimedia interview series.

A phase 3 analysis found that CKD-701, a ranibizumab biosimilar candidate developed by CKD Limited, has comparable clinical efficacy and safety with the reference product (Lucentis) in patients with neovascular age-related macular degeneration (nAMD).

Here are the top 5 biosimilar articles for the week of January 23, 2023.

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.

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.

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.

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.

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.

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.

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).

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

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.

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