Regulatory

Otulfi was approved simultaneously in the European Union. In the US, it will launch in February 2025.

The European Commission (EC) approved Celltrion's ustekinumab biosimilar for chronic inflammatory diseases, Celltrion expanded access to Zymfentra (subcutaneous infliximab-dyyb) through partnerships with Cigna and Express Scripts, and the Association for Accessible Medicines held a policy briefing addressing barriers to biosimilar adoption.

The Inflation Reduction Act (IRA) has modestly boosted oncology biosimilar uptake through Medicare reimbursement, but its impact has been limited due to preexisting competitive market conditions.

Amgen’s Pavblu (aflibercept-ayyh) is the fifth biosimilar referencing Eylea (aflibercept) to be approved for American patients with retinal diseases.

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.

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.

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.

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.

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.

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

Manitoba’s new policy means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

The number of FDA-approved biologics has exploded, and biosimilars are making their mark.

The FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

In a position paper from the Biosimilars Council, the organization points to evidence showing that clinical efficacy trials are a major barrier to biosimilar access in the US, calling for the FDA to change its policies to remove them in favor of other comparators.

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

Sarfaraz K. Niazi, PhD, congratulates the FDA on approving the 50th biosimilar, noting that there's more work to be done to expand the market.

As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.

Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.

The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.

The approval marks the sixth for a biosimilar referencing Herceptin (trastuzumab) for the treatment of HER2-positive breast and gastric cancers.

The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.

Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

Tyenne (tocilizumab-aazg) was the second tocilizumab biosimilar to be FDA approved, but it is the first to launch in the US.

Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.