Regulatory

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.

Health care policy expert Jane Halton, AO, PSM, has been picked for her extensive experience in governmental health affairs.

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate.

The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.

Anurag S. Rathore, PhD, wins a grant and the use of scientific instruments from Agilent to further his investigation.

To spur more biosimilar development and reduce anticompetitive practices, the company argued the FDA could improve its interpretation of the term “strength” in the Biologics Price Competition and Innovation Act (BPCIA).

A survey of 20 countries highlights the remaining regulatory challenges facing biosimilar adoption.

The FDA clarified a number of concerns surrounding the appropriate procedures for industry to apply for interchangeability status.

Biosimilar suffixes were intended to help with pharmacovigilance, but they are not widely understood.

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.

Prior to the turmoil of the pandemic, the FDA and CMS were at work on shoring up the biosimilars market, and this work continues on various fronts, a regulatory/policy expert explains.

The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

Results up to week 52 in the phase 3 study show that primary end points were met for best corrected visual acuity and central subfield thickness.