Policy

The Future of Biosimilar Gene Therapies: Key Issues and Potential

September 11th 2024

By Skylar Jeremias

Article

While biosimilars could potentially lower costs and improve access to gene therapies, significant hurdles in regulation, manufacturing, intellectual property, and market size pose challenges to their development and market entry.

BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars

September 9th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.

The Role of Coverage Strategies in Biosimilar Market Impact and Cost Savings

September 4th 2024

By Skylar Jeremias

Article

A recent study highlights that although biosimilars have led to significant price reductions, originator products with sole preferred coverage strategies have maintained market share, suggesting that increased biosimilar uptake alone may not fully leverage the market's competitive and cost-saving potential.

Upcoming Biosimilars and the Impact of IRA: Key Takeaways From Jeffrey Casberg

September 3rd 2024

By Cameron Santoro

Article

Jeffrey Casberg discusses key upcoming biosimilars and specialty drugs, the impact of the Inflation Reduction Act on drug pricing, and the evolving role of pharmacy benefit managers in the market.

The Economic Impact of Etanercept Biosimilar Remonopolization in Poland

August 28th 2024

By Skylar Jeremias

Article

Market remonopolization by a biosimilar drug in Poland led to significant price increases for etanercept, resulting in over €3.42 million in excess health care costs, according to a recent study.

BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit

August 26th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.

Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results

August 21st 2024

By Skylar Jeremias

Article

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel

August 19th 2024

By Skylar Jeremias

Article

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

FDA Approves Biosimilar Enzeevu for Eye Conditions

August 12th 2024

By Skylar Jeremias

Article

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

AI and Biosimilars: Bridging Global Health Disparities and Enhancing Treatment Efficiency

August 10th 2024

By Skylar Jeremias

Article

Artificial intelligence (AI) technologies can support global health systems in integrating biosimilars into care models, reducing health care costs, enhancing treatment decision-making strategies, and narrowing the gap between high-income and low- and middle-income countries.