Regulatory

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.

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests.

Charles Bennett, MD, PhD, a hematologist and oncologist and professor in the Clinical Pharmacy and Outcomes Sciences Department of the College of Pharmacy at the University of South Carolina, discussed the FDA’s pace of biosimilar approvals and the findings from his recent study.

Authors of a new study conclude that artificial intelligence could improve the selection of biosimilars for therapy.

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.

Many firsts may be in store for the biosimilar industry in 2021, although it will be dogged by ongoing difficulties, Center for Biosimilars® Advisory Board members said.

Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.

In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020.

MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.

Intellectual property law attorneys from Axinn discuss regulatory and legal events in 2020 that will affect biosimilar markets in 2021.