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On this episode of Not So Different, we recap some of the big regulatory news to come out of November, including some progress for insulin biosimilars, the European approval of another ranibizumab biosimilar, and the congressional introduction of a US Senate bill that is seeking to nix switching study requirements for interchangeability.

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.

Here are the top 5 biosimilar articles for the week of November 28, 2022.

In November, several global agencies progressed insulin biosimilars, the European Union approved another ranibizumab biosimilar, and a US Senate bill to rid switching study requirements for interchangeability was introduced to Congress.

Now that the world population has reached 8 billion, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, took a look at how high-income countries can increase accessibility to livesaving medicines to the 7 billion people who have limited access to biosimilars.

Capstone has announced that its human insulin biosimilar received positive opinions from the European Medicines Agency and Health Canada, signaling approvals may be on the horizon, and the acquisition of Viatris’ biosimilars portfolio by Biocon Biologics is officially complete.

After receiving FDA approval in February 2022, Amneal Pharmaeuticals and Kashiv Biosciences launched Releuko (filgrastim-ayow) on the US market, making it the fourth biosimilar referencing Neupogen to be commercially available to Americans.

Regence found that implementing strategies to increase its biosimilar adoption rate reduced spending on specialty drugs by $37 million annually. The organization is the latest example of how biosimilar use has contributed to significant savings.

Chad Pettit, the executive director of marketing and global biosimilars commercial lead at Amgen, discusses the most recent version of Amgen's Biosimilar Trends Report and what the report says about the current biosimilar market and how it could develop in the years to come.

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).

Here are the top 5 biosimilar articles for the week of November 21, 2022.

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

The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.

The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.

In Biocon’s second quarter of fiscal year 2023 earnings report, revenues were up 23% year over year (YoY) for the company, largely in thanks to the 34% increase in revenues for biosimilars and accounting for 42% of the total company revenue.

Technology utilizing electronic medical records pathways can be useful for practices struggling to manage multiple biosimilars for the same reference product, according to Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute.

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.

Here are the top 5 biosimilar articles for the week of November 14, 2022.

Organon Canada launches 2 biosimilars referencing Avastin (bevacizumab) and Herceptin (trastuzumab), China became the first country to approve a denosumab biosimilar, and Optum Rx, a large pharmacy benefit manager (PBM), said that it will add adalimumab biosimilars to formulary.

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, describes how local health policy initiatives can help providers and patients feel more comfortable with the idea of interchangeable biosimilars.

The European Union has approved a third biosimilar referencing Lucentis (ranibizumab), STADA Arzneimittel and Xbrane BioPharma’s Ximluci, for the treatment of retinal conditions.

A moderated digital open forum facilitated an interactive discussion among health care professionals, health system executives, health care payers, and health policy influencers about promise and the barriers to the expanded use of biosimilars in ophthalmic applications.

Craig Burton, senior vice president of policy and strategic alliances at the Association for Accessible Medicines and executive director of the Biosimilars Council, gives insight into the many health policies that the Biden administration has implemented in 2022 as well as their possible impact on biosimilar adoption.

The efficacy and safety of bevacizumab biosimilars in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) is comparable with the reference product (Avastin) and each other, according to a meta-analysis.

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.

Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.

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.

Sarfaraz K. Niazi, PhD, dived into the benefits of the FDA's recently announced Biosimilar Regulatory Science Program, which is expected to help progress biosimilar development and simplify evaluations for interchangeability status.

On this episode of Not So Different, we recap some of the biosimilar policy news from the around the world during October, including the implementation of a biosimilars switching policy, the European Union declaration of biosimilars as interchangeable, and the reauthorization of the Biosimilars User Fee Act.

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.