Rheumatology

The FDA has accepted Biogen’s biologics license application for a tocilizumab biosimilar candidate (BIIB800) referencing Actemra for review.

Following their initial European launch of the drug, Alvotech and STADA Arzneimittel launch their adalimumab biosimilar referencing Humira in 7 more European countries: Belgium, Bulgaria, Croatia, the Czech Republic, Latvia, Romania, and Slovenia.

Iceland-based Alvotech received regulatory approval for AVT02, its biosimilar referencing Humira (adalimumab), from the Therapeutic Goods Administration of Australia.

If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.

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.

Abstracts presented at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting explored the adoption of infliximab biosimilars, utilization patterns of bevacizumab biosimilars in ophthalmology and oncology settings, and the budget impact of transferring patients to a natalizumab biosimilar from the originator.

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.

A report from IQVIA recapped the US experience with Semglee, an insulin glargine biosimilar that has versions with and without an interchangeability designation, to help predict the adoption patterns of adalimumab biosimilars when they enter the market in 2023.

A report from Cardinal Health tells that rheumatologists are more familiar and confident in biosimilars compared with 2020, showing that education efforts are effective and that rheumatologists are more willing to prescribe biosimilars to their patients.

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.

A placebo-controlled clinical trial found that rituximab biosimilar HLX01 in combination with methotrexate was successful at improving the clinical outcomes of patients with moderate-to-severe rheumatoid arthritis.

The final part of this 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy consideration they can implement to reap the benefits of biosimilar savings.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, chronicles how drug prices as a result of biosimilar competition has evolved over time and what factors may contribute the most to price erosion.

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.

The third installment of this 4-part series dives into how providers, administrators, nurses, and pharmacists can prepare for adalimumab biosimilars and what role they can play in patient acceptance and use of biosimilars.

The second part of this 4-part series looks at what patients and employers can expect when adalimumab biosimilars hit the market.

As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to maintain a robust market.

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

In the first article of a 4-part series, The Center for Biosimilars® offers specifics for each of the adalimumab biosimilar products coming in 2023 and explains why the experience in Europe may differ from what’s coming in the United States.

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

A review article chronicled the emergence of anti-inflammatory biosimilars in the United States and European Union and made predictions for where the market is headed, especially as etanercept and adalimumab biosimilars gain more prominence.

Researchers found that an infliximab biosimilar was as safe and effective as the reference product (Remicade) in pediatric patients with inflammatory bowel disease. However, more studies on adalimumab biosimilars in pediatric patients are needed.

The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.

Study authors found the pair of biosimilars performed as well as others that have been evaluated in inflammatory bowel disease (IBD), but concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

In a statement, Fresenius Kabi officials said the company is rapidly expanding its portfolio in autoimmune and oncology conditions.

Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.

Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.