News

Over 2 years after a cabinet vote to establish a biosimilar switching policy, the Ontario government is putting one in place, making it the seventh province and eighth jurisdiction in Canada to do so.

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.

Janssen filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.

On this episode, Brian Biehn, senior director of biosimilar commercialization at AmerisourceBergen, explored how the new year may play out for biosimilars, including his predictions or how uptake will be influenced in the adalimumab market and how government policies will impact the competitiveness of the market.

Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

Here are the top 5 biosimilar articles for the week of December 12, 2022.

Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

In his newest column, Sarfaraz K. Niazi, PhD, looks into the domestic and international support for removing interchangeability for biosimilars in the United States.

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

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, shares how the recent codevelopment deal between Similis and Blau Farmaceutica differs from commercialization and licensing deals many other companies have signed with each other.

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.

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

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.

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, talked about the challenges associated with launching a business venture like Similis Bio and how Similis Bio's business model differs from other biosimilar developers and their spin-offs.

Prime Therapeutics has officially acquired Magellan Rx Management, a popular pharmacy benefit manager (PBM) in the specialty pharmacy space. The acquisition was announced in May 2022 and includes the acquisition of Magellan Rx’s specialty, PBM, and government pharmaceutical and Medicaid business segments.

The Accreditation Council for Medical Affairs (ACMA) is launching a new program for health care professionals to become Board Certified Biologics and Biosimilars Specialists.

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.