Development

Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, details how biosimilar guidelines from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.

The American College of Rheumatology (ACR) steadfastly supports the availability of safe and effective treatments for patients at the lowest cost possible, and underscores the necessity of scientific rigor for biosimilar use and approval.

Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, gave a keynote presentation at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.

In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. However, biosimilars have also encountered the harsh realities of the US health care system and its market forces.

Biocon Biologics and its partner Viatris received a complete response letter (CRL) for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.

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.

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).

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.

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.

In his column, Sarfaraz K. Niazi, PhD, chronicles the potential for biosimilars referencing some of the biggest cell and gene therapies as well as why companies should begin looking into biosimilar development efforts in this space.

IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report demonstrated successful uptake in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, shares his perspective on how clinical efficacy testing and recent actions from the Biden Administration, such as the executive order on biotechnology investment, impact biosimilar development.

Sarfaraz K. Niazi, PhD, breaks down the current status of biosimilar development and makes suggestions for which molecules manufacturers should target next in his newest column installment.

A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.

The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found PK and PD equivalence between the biosimilar insulin-70/30 and Humulin-70/30.

The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).

A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that providers should consider the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.

As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announces an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiates a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions begins a phase 3 trial for a secukinumab biosimilar.

Authors of a plain-language summary of the VOLTAIRE-RA study examined how to help patients with rheumatoid arthritis (RA), their families, patient advocates, and health care professionals learn about potential new treatment options as the United States prepares for the introduction of adalimumab biosimilars.

Biosimilar and generic drugs accumulated $373 billion in savings in 2021, $7 billion of which can be attributed to biosimilars alone, according to a report from the Association for Accessible Medicines (AAM).

Authors of a systematic review summarized the results of 21 published studies on the efficacy, safety, and cost-benefit ratio of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.

Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.

A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.