News

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

Here are the top 5 biosimilar articles for the week of December 14, 2020.

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.

Samsung Bioepis hopes to gain regulatory approval for a denosumab biosimilar referencing Prolia. The trial will focus on women with postmenopausal osteoporosis.

In little over 1 year of use in patients with breast cancer, trastuzumab biosimilars have seen rapid growth in uptake.

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.

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.

Here are the top 5 biosimilar articles for the week of December 7, 2020.

Two studies of trastuzumab biosimilars have improved understanding of these medicines as monotherapy and in combination with other agents in metastatic breast cancer.

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

Investigators explained the potential for durable antitumor efficacy in patients with human epidermal growth factor receptor 2 (HER2)-expressing or -driven tumors who have exhausted other treatment options.

A high overall response rate of 93% was observed for patients with immune thrombocytopenic purpura who received romiplostim biosimilar.

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

A long-term, comparative, phase 3 trial of CT-P10 vs the rituximab originator product has provided evidence of biosimilar value in this blood disorder.

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).

Here are the top 5 biosimilar articles for the week of November 30, 2020.

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.

The wearable injector has a failure rate that adds hospitalization costs; therefore, biosimilar pegfilgrastim may hold cost advantages, investigators conclude.

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.

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.

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.

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.