Biosimilars and Biobetters

Process consistency and robustness, analytical excellence, and regulatory compliance are essential in the scale-up of biosimilars.

Omlyclo (omalizumab-igec) was approved to treat moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and certain food allergies.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

Weighing development costs/resources and performance benefits is essential.

BioPharm International® spoke with Zara Bukhari, a PhD scholar at the University of the Pacific, Stockton, CA, and co-author of the peer-review research paper, Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials, published in the July/August 2024 issue, about process development for biosimilars.

The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.

STADA and Alvotech have launched Uzpruvo, the first approved biosimilar to Stelara (ustekinumab), in the European market, marking the second biosimilar brought to market by this partnership.

Biosimilar analytical assessments focus on demonstrating biosimilarity and interchangeability with the reference biologic.

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Despite a growing number of biosimilar approvals, market uptake remains a challenge.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.

Analytical characterization of biosimilars plays a crucial role in a successful path to regulatory approval.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Lilly will cap insulin prices for patients with and without insurance at $35 per month.

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Linking structure with function is paramount.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.

The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.