News

A recent opinion column outlines some principles to consider when thinking about changing the current US system of financing drug innovation, especially potentially curative therapies.

The Center for Biosimilars® recaps the top stories from the first half of 2020.

Rituximab was originally approved in the United States in 1997 for treatment of non-Hodgkin lymphoma and has multiple additional approvals for orphan and nonorphan indications. But a recent study found off-label uses now account for more than half of patients receiving rituximab.

Sandoz said it was reviewing all options, including a possible appeal to the Supreme Court. The case concerns Amgen's originator drug Enbrel and the biosimilar Erelzi.

As the coronavirus disease 2019 pandemic continues to hinder the forward momentum for biosimilar approvals, FDA has shown that biosimilars are still a priority for the agency.

The widespread adoption of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic, as well as reimbursement parity that was enacted by CMS, should be continued once the public health emergency passes, according to a new position statement by the American College of Rheumatology (ACR).

A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

Japanese authorities have given marketing approval for the first adalimumab biosimilar in that country.

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

In surveys conducted in February and March 2020, rheumatologists cited low adoption rates of biosimilars by payers and unfavorable discounts as major reasons why they feel uncomfortable switching prescribing patterns from reference products to biosimilars.

The US Oncology Network is pushing to get more biosimilars into utilization, Robert M. Rifkin, MD, told The Center for Biosimilars® in an interview.

Based on clinical studies on dosing, efficacy, and pharmacokinetics, European authorities have recommended Celltrion's subcutaneous infliximab biosimilar (Remsima SC) for 5 new indications.

Patients have problems getting timely authorizations for specialty meds and physicians face time burdens in getting them approved, a new report from CoverMyMeds says.

New prediction methodology for calculating biosimilar application fees will help the FDA cover its costs and respond quickly to changes in demand, officials said at a public meeting.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

Here are the top 5 biosimilars articles for the week of June 22, 2020.

Republican opponents of the Affordable Care Act (ACA), led by the state of Texas, fired opening salvos in the Supreme Court case over the landmark law's constitutionality. If the entire law is thrown out, approval for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) would disappear, too.

HLX14, a denosumab biosimilar targeted for the treatment of postmenopausal osteoporosis in patients with a high risk of fractures, was approved by China’s National Medical Products Administration (NMPA).

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

First-quarter earnings for German biosimilar developer, Formycon AG, has shown that early measures taken to mitigate the effects of the coronavirus disease 2019 (COVID-19) pandemic have paid off.

The currently available anti–vascular endothelial growth factor (anti-VEGF) therapies for wet age-related macular degeneration (AMD) are costly, but biosimilars in clinical development may ease this problem.

This spring, The Center for Biosimilars® interviewed a variety of thought leaders for their opinions on the US biosimilar market so far in 2020 and the barriers that need to be addressed. Here are some highlights.

A joint position statement on biosimilars for the treatment of inflammatory bowel disease (IBD) sparked backlash and criticism over the recommendation against nonmedical switching from reference infliximab to a biosimilar.

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

China’s National Medical Products Administration (NMPA) has accepted an application for a biosimilar bevacizumab developed by Bio-Thera Solutions for treatment of certain lung and colorectal cancers.

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Here are the top 5 biosimilars articles for the week of June 15, 2020.

HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

In response to pharmaceutical supply chain disruptions caused by the coronavirus disease 2019 (COVID-19) pandemic, a panel of experts called for big changes; attention to detail is key to making sure the outcomes are successful.