Regulatory

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.

The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape.

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.

A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.

Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.

An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be followed by a European Commission final decision early in 2021.