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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.

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.

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.

In the EU-5 group of countries, biosimilar awareness is poor, hindering uptake of these potentially cost-saving medicines, a white paper states.

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.

The Songdo district of Incheon, Republic of Korea, is rapidly becoming a major biopharmaceuticals production center.

In November, the Supreme Court heard arguments on the Affordable Care Act, Europe fired up its efforts to create a more biosimilar-friendly environment, and Genentech fought to protect its bevacizumab franchise.

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.

Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.

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

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

Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.

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

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

In Europe, the pandemic has revealed problems within health care systems and the need to increase access to biosimilars and reform health care policies.

Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.