Skylar Jeremias

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.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar and whether it will impact future patent lawsuits.

Although Roche’s earnings report for the first quarter of 2022 showed overall increases, products like Herceptin, Avastin, and Rituxan continue to lose revenue due to biosimilar competition.

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting highlighted the clinical similarity of a trastuzumab biosimilar compared with its reference product and real-world longitudinal application of infliximab biosimilars.

Here are the top 5 biosimilar articles for the week of April 18, 2022.

Patients and other stakeholders received some biosimilar news, with a small recall for Mylan’s unbranded insulin glargine biosimilar and the completed full acquisition of Samsung Bioepis into Samsung Biologics.

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.

A phase 3 study conducted by Amgen found that the company’s ustekinumab biosimilar was as safe and efficacious as the reference product (Stelara) in patients with moderate to severe plaque psoriasis.

Here are the top 5 biosimilar articles for the week of April 11, 2022.

Access to new treatment options for ophthalmic conditions and diabetes is on the rise with the launch of Sandoz’ generic ocular hypertension medication, a new deal to bring a ranibizumab biosimilar to the Middle East, and the initiation of a trial for an insulin glargine biosimilar.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.

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

Switzerland-based company Fresenius Kabi announced that its pegfilgrastim biosimilar received marketing authorization in Europe and that it has obtained a majority stake in biosimilar manufacturer mAbxience and acquired its subsidiary.

Here are the top 5 biosimilar articles for the week of April 4, 2022.

Edward Arrowsmith, MD, discussed his recent paper on the use of clinical pathways for specific cancer types and how biosimilar development can help ensure quality of care for patients with limited therapeutic options.

Chelsee Jensen, PharmD, and Eric Tichy, PharmD, MBA, who coauthored a paper on the Mayo Clinic's success with implementing biosimilars, discuss their study and how their practice is expected to evolve to improve its approach.

During the month of March, rheumatology biosimilars have received a lot of praise in a regulatory, business, and legal sense, especially regarding the landmark settlement between Alvotech and AbbVie over an adalimumab biosimilar.

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, explains why there's no easy to solution to getting the US biosimilar market to the same level as Europe.

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.

Alvotech and Fuji Pharma signed a deal for a biosimilar in Japan; Signet partnered with Juno Pharmaceuticals to grow equity investment; and Sandoz expanded its ability to produce generic respiratory drugs by acquiring Coalesce.

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

Three biosimilars used for blood clot prevention secure public reimbursement status in British Columbia, one of several Canadian provinces that has a biosimilar switching program.

An international phase 3 study of patients with erb-B2 receptor tyrosine kinase 2-positive (ERBB2+) breast cancer showed that Tuznue, a trastuzumab biosimilar, had comparable safety and efficacy to the reference product (Herceptin).

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.

Kathy Oubre, MS, chief executive officer of Pontchartrain Cancer Center, explains the progress she has seen regarding biosimilar utilization and acceptance.

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.

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

Gillian Woollett, MA, Dphil, vice president and head of regulatory strategy and policy at Samsung Bioepis, reviews some of the presentations, including her own, from the Festival of Biologics conference.

OcyonBio signed a Good Manufacturing Practice (GMP) agreement for the manufacturing of biosimilars in Puerto Rico, while Evio Pharmacy Solutions implemented a strategy aimed at increasing biosimilar affordability.

A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.