Skylar Jeremias

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.

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.

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.

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.

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.

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.

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.

Here are the top 5 biosimilar articles for the week of October 31, 2022.

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.

Two studies presented at the American Academy of Ophthalmology (AAO) annual meeting in Chicago, Illinois, demonstrated the impact that a ranibizumab biosimilar (SB11; Byooviz) can have on patient outcomes.

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).

October ushered in a number of policy updates, 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.

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, offers advice to health systems on how they can incorporate some of Emory Healthcare's strategies to promote biosimilar uptake.

Here are the top 5 biosimilar articles for the week of October 24, 2022.

Similis Bio signed a licensing and codevelopment agreement with Blau Farmacêutica, allowing the latter to have exclusive development and marketing rights to 4 biosimilar assets in Latin America.

Speakers during a LinkedIn Live panel discussion expressed a dire need for all stakeholders to work together to increase education efforts, provide clarity on safety and interchangeability, and encourage adoption of biosimilars in ophthalmology.

Genentech and Roche have voluntarily recalled their ophthalmology biobetter, Susvimo, an ocular implant for ranibizumab injection, in the United States for a possible leakage issue.