Business

A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.

By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.

Sarfaraz K. Niazi, PhD, provides an overview of the current biosimilar education material offered by the FDA, emphasizing that manufacturer-developed materials aren't needed.

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.

For biosimilars to overcome these entrenched market dynamics, they must not only compete on price but actively work to build a network of support among providers and patients.

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.

Part 2 of our series diving into the Association for Accessible Medicines' (AAM) latest report discusses that while generics and biosimilars saved $445 billion in 2023, their potential is hindered by high patient costs, drug shortages, and ineffective policies, underscoring the need for reforms to fully realize their benefits.

The article by Sarfaraz K. Niazi, PhD, critiques the irrationality surrounding biosimilars, suggesting that regulatory changes and cost reductions in manufacturing could make biosimilars as affordable as generic drugs.

Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the Association for Accessible Medicines (AAM).

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

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.

German biosimilar manufacturer STADA Arzneimittel reported a 9% revenue increase in the first half of 2024, with over €2 billion in sales, driven in part by biosimilar successes and new product launches.

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.

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.

On this episode of Not So Different, the end of the second quarter brings with it expense reports, new biosimilar business deals, and insights into how federal policy impacts biosimilar company pursuits.

With the end of the second quarter comes expense reports, new biosimilar business deals, and insights into how federal policy impacts biosimilar company pursuits.

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.

Sandoz’ earnings report for the first half of 2024 revealed 29% growth in biosimilar revenue, as well as a 7% increase in net sales, showcasing the value of biosimilars for biopharmaceutical manufacturers.

Alvotech reported $236 million in revenue for the first 6 months of 2024, a 10-fold increase from the same period the year prior. The new figures come after the company received its first 2 FDA approvals in 2024.

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 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.

Formycon's first half 2024 revenue was €26.9 million, boosted by its ranibizumab biosimilar sales but down from last year due to fewer upfront payments and deferred success payments.