Skylar Jeremias

January started the year off strong, with several business updates, long-term clinical trial results on multiple biosimilars, and the FDA approval of the third tocilizumab biosimilar.

January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

The FDA approved Avtozma, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.

SB5, an adalimumab biosimilar approved in the US, is showing to be safe and effective for patients with psoriasis in the long term, according to a study from the UK and Ireland.

Eculizumab biosimilar Elizaria demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

Three players in the biosimilar space have already sparked hope for the new year, with each having big business or regulatory announcements regarding new biosimilar products in Europe and Canada.

Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

When compared with reference aflibercept, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.

Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

The nationwide mandatory switch from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.

Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

Celltrion’s denosumab biosimilar demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.

The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

Tiago Biachi, MD, PhD, emphasizes that biosimilars are vital for reducing financial toxicity and ensuring equitable, affordable access to advanced treatments in gastrointestinal (GI) cancer care, while calling for dynamic policies and greater cost awareness among clinicians.

To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.

The top 5 biosimilar-related articles of the year highlight a significant shift in the pharmaceutical industry, with projections indicating strong uptake in biosimilars at the expense of the originator products, despite challenges like uptake disparities and safety concerns.

The 2024 surge in FDA approvals for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.

The top 5 rheumatology biosimilar articles of 2024 highlight significant FDA approvals, including high-concentration adalimumab and tocilizumab biosimilars, along with evidence supporting the safety and efficacy of biosimilar-to-biosimilar switching.

On this episode of Not So Different, we reflect on 2024 and this show in particular, taking audiences back through the most popular podcast episodes of the year.

The top biosimilar policy articles of 2024 highlight advancements that include FDA guidance to simplify biosimilar interchangeability and CMS drug price negotiations under the Inflation Reduction Act, alongside challenges posed by pharmacy benefit manager rebate practices and the need for more active stakeholder engagement.

Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.

The top 5 biosimilar conference articles in 2024 highlight significant progress in the biosimilar landscape, including strategies for market sustainability, safety of switching to biosimilars, and substantial savings through high biosimilar adoption, while also addressing ongoing challenges.

In 2024, significant biosimilar approvals were granted by the American and European regulatory agencies, including the first interchangeability designations for biosimilars referencing ustekinumab, adalimumab, denosumab, and aflibercept, marking key regulatory milestones in improving patient access to cost-effective treatments.

The top 5 oncology biosimilar articles in 2024 cover Duke's recommendations for cell and gene therapy biosimilars, FDA approval of Shanghai Henlius Biotech's trastuzumab biosimilar, Boehringer Ingelheim layoffs, the safety of rituximab biosimilar CT-P10, and more.

The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.