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.

Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

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.

No significant difference in the risk of serious infections between etanercept and infliximab biosimilars and their original brand-name medications was identified.

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.

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

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.

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.

The top gastroenterology biosimilar news from 2024 highlight fluctuations in the adalimumab biosimilar market throughout the year, while FDA and European approvals for ustekinumab biosimilars are set to improve access and reduce costs for patients with Crohn disease and ulcerative colitis.

China's trastuzumab biosimilar market is growing but lags behind European countries, with biosimilars gradually increasing market share and reducing costs despite initial barriers.

The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.

Recent discussions at an Institute for Value-Based Medicine event highlighted the significant potential of biosimilars in reshaping the health care landscape, despite facing considerable barriers to adoption.

A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.