Regulatory

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.

As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its third recall for a batch of its insulin glargine biosimilar over missing labels.

So far in 2022, the United States has taken some big steps in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

The European Committee for Medicinal Products for Human Use (CHMP) recommended 2 biosimilars for approval: Celltrion Healthcare’s bevacizumab candidate and Formycon’s prospective ranibizumab product.

Not long after the company announced its new global initiative to promote access and increase adoption of biosimilars, Sandoz’ biologics license application for its high-concentration adalimumab biosimilar was accepted by the European Union’s regulatory agency for review.

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.

The FDA approved Fylnetra, the fifth approval for a pegfilgrastim biosimilar in the United States.

With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering a new phase of biosimilar use.

A study assessing the impact of mandatory switching policies in British Columbia on patients with rheumatic conditions receiving infliximab therapy found that switching to a biosimilar did not result in increased health service use.

The European Committee for Medicinal Products (CHMP) rejects Prestige Biopharma’s biosimilar referencing Herceptin; Prime Therapeutics’ plan to leverage biosimilars resulted in savings for patients; Samsung Biologics and AstraZeneca liquidated their joint venture (Archigen Biotech).

Viatris and Biocon Biologics announced the launch of their bevacizumab product, Abevmy, a biosimilar to Avastin, on the Canadian market.

Altering reimbursement procedures needs to become a bigger priority for government officials to incentivize biosimilar utilization, according to Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System.

The United Kingdom has approved Teva Pharmaceutical’s biosimilar (Ongavia) that references Lucentis (ranibizumab) for the treatment of several ophthalmic conditions.

Julie M. Reed, the executive director of the Biosimilars Forum, discusses how biosimilar savings can differ between stakeholders and the importance of competition for creating those savings.

A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.

Stacie B. Dusetzina, PhD, is the Ingram Associate Professor of Cancer Research at Vanderbilt University Medical Center, and a member of the editorial board for The American Journal of Managed Care®.

The main takeaway from the House Energy and Commerce Committee hearing on HHS's 2023 budget was that biosimilars were not mentioned as much as they should have been, said Julie M. Reed of the Biosimilars Forum.

The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.

Eric Tichy, PharmD, MBA, vice chair of pharmacy formulary at the Mayo Clinic Health System, discusses the importance of state legislation to boost biosimilar access and uptake.

Now that the United States’ acceptance of biosimilars matches that in the European Union, developers should be encouraging changes to testing regulations to increase biosimilar accessibility, according to Sarfaraz K. Niazi, PhD, in his recent perspective paper.

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Medicare Part D plans missed out on between $84 million and $143 million in savings by not prioritizing the use of biosimilars over reference products, according to a report from the HHS Office of Inspector General.

Republic of Korea-based Celltrion Healthcare launched its high-concentration adalimumab biosimilar in Canada and won several Brazilian tenders to supply its infliximab biosimilar.

The executive director of the Biosimilars Forum calls for policies to support adoption of lower-cost biologics.

An article reviewed the totality of evidence leading to the approval of Amgen’s infliximab biosimilar ABP 710 (Avsola), which is currently approved in the US and Canada for all the indications of the originator (Remicade).

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, previews his sessions about the new and emerging pharmaceutical products coming down the pipeline at the upcoming Academy of Managed Care Pharmacy (AMCP) annual meeting.

Since the start of 2022, China’s National Medicinal Products Administration (NMPA) has made strides to increase access to biosimilar products for various rheumatic conditions, including 3 biosimilar approvals and 1 biosimilar receiving an expanded indication.

As HHS prepares to begin a study that will summarize the use and spending of biosimilars within Medicare Part B plans, the FDA updates its clinical trial guidance to expand enrollment access to senior patients.