Regulatory

The Biologics Price Competition and Innovation Act has been around for 10 years, but grey legal areas still abound, Goodwin attorneys note.

Lannett modifies a pivotal trial design to ensure a smoother ride through the FDA product review.

Alteogen is among a number of contenders vying to bring aflibercept biosimilars to market. Key patents on the originator begin to expire in 2023.

Regulatory and launch news on rheumatology biosimilars for adalimumab and infliximab was plentiful in February 2021.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

The National Comprehensive Cancer Network (NCCN) recommended providers contact their legislators to counteract single-biosimilar payer policies.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

In a review of trastuzumab treatment options, reviewers concluded subcutaneous (SC) vs intravenous (IV) options may be more costly and sometimes less practical.

Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer.

The Germany-based company with global operations plans to ramp up its biosimilars portfolio through 2025.

Huiya Wu, JD, and Freddy Yip, PhD, PCLL, attorneys at Goodwin Procter, discussed projections for the Chinese biosimilars market and the potential for foreign companies to get a share.

Fresenius Kabi steps into the Canadian market for adalimumab with Idacio.

Coherus BioSciences filed a 351(k) biologics license application (BLA) for CHS-1420, an adalimumab biosimilar candidate.

The launch of Hyrimoz gives Sandoz 5 biosimilars on the Canadian market. National policies on switching have given biosimilars a tailwind.

The marketing of Yuflyma is expected to give Celltrion Healthcare a significant advantage over existing adalimumab biosimilars.

Biosimilars, supply chain adjustments, building trust, and international standardization were discussed as means to deliver innovation when it's needed, not after.

The Bengaluru, India, company said the fast-acting biosimilar will improve affordability of insulin in Europe, which also faces rising prices and access problems.

Lannett and HEC Pharm are developing an insulin aspart biosimilar on the heels of their insulin glargine codevelopment project.

China’s regulatory reforms and policy enhancements bode well for a thriving biosimilars industry.

Celltrion aims to try a direct marketing approach in Canada to streamline sales of its subcutaneous form of Remsima.

Test your knowledge of biosimilar approvals in China.

Guangzhou, China-based Bio-Thera has filed a biologics license application (BLA) with the FDA for the approval of bevacizumab biosimilar candidate BAT1706.

In its annual drug price guide, Vizient predicts that US annual adalimumab (Humira) revenues could reach $24 billion before biosimilars enter the marketplace.

Charles Bennett, MD, PhD, a hematologist, oncologist, and professor at the University of South Carolina, explained the many sticking points that prevent biosimilar savings.

It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.

Consistency of reporting quality attributes for biosimilars may differ, complicating the job of getting a full picture of biosimilarity.

Biosimilars will be the cornerstone for a leap into biologics development and commercialization, according to the CEO of Prestige Biopharma. Also, Innovent Biologics reaches a marketing agreement.

Many patient advocates hope that expansion of the Biologics Price Competition and Innovation Act (BPCIA) will bring further competition to the insulin market—and lower prices.

The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.

Samsung Bioepis has filed for FDA approval for a ranibizumab biosimilar candidate (SB11), and more ophthalmology biosimilars are in the pipeline.