Business

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.

IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.

Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health in Sacramento, California, details the regulatory decisions from 2022, what's to come in 2023, and how the US biosimilars market is expected to shift over the next 5 years.

As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.

Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.

IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report demonstrated successful uptake in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrates why regulatory bodies in the United States shouldn't look at economic evaluations when reviewing regulatory data for biosimilars in his latest column.

Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, shares his perspective on how clinical efficacy testing and recent actions from the Biden Administration, such as the executive order on biotechnology investment, impact biosimilar development.

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.

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.

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.

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.

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.

If every adalimumab biosimilar had an interchangeability designation, the United States could save additional $765 million annually, according to calculations from 3 biosimilar experts.

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).

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.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, explores whether biosimilars should be considered a commodity and if the commodification of medications is sustainable as the market continues to expand.

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.

Amgen’s ninth edition of its Biosimilar Trends Report explores the evolution of the US biosimilar industry, including current trends, predictions for the next few years, advice for stakeholders going forward, and insight into how reimbursement and other policies could develop.

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, chronicles how drug prices as a result of biosimilar competition has evolved over time and what factors may contribute the most to price erosion.

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.

In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.

As the United Kingdom adds another oncology biosimilar to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.