Skylar Jeremias

A phase 1b/2 trial evaluating a trastuzumab biosimilar as part of a first-line triplet regimen demonstrated significant tumor shrinkage in HER2-positive advanced gastric cancer.

The European Commission has granted market authorization to Sanofi for its insulin aspart biosimilar, making it the first approved biosimilar to NovoRapid for the region.

Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

A review laid out ways for nurses to address patients’ questions on biosimilars in order to help them take on the role of improving utilization rates in cancer treatment.

Sandoz Canada launched a digital campaign to provide fact-based materials on biosimilars in hopes of spreading awareness on the benefits of biosimilars for physicians and patients.

A Senate bill that seeks to establish a shared savings model to help increase access and encourage physician use of biosimilars was introduced.

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.

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

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 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.

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).

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.

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.

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 is a summary of our coverage from EHA25 Virtual, the annual meeting for the European Hematology Association (EHA).

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.

Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts.

In search of effective treatments for patients hospitalized with coronavirus disease 2019 (COVID-19), investigators will test an infliximab biosimilar (Remsima, CT-P13). They believe it may help to control cytokine release syndrome, which is associated with COVID-19.

Although biosimilar uptake has been slow in the United States, the current administration has enacted several policies to help speed up the process, according to Michael Kolodziej, MD, who presented at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Conference.

As the United States struggles to increase biosimilar uptake, a researcher believes that establishing a shared savings model for Medicare Part B drugs could provide valuable insight into how changing reimbursement patterns could increase utilization.

Canada Health has approved the launch of Sandoz' pegfilgrastim and rituximab biosimilars.

Xbrane Biopharma said it needs a new lab and headquarters because of rapid growth and ambitious plans for biosimilar development.

Mylan and Lupin have received market authorization for their etanercept biosimilar (Nepexto, YLB113) in Europe for all indications of the reference product.

Here is a summary of our coverage from ASCO20 Virtual, the annual meeting for the American Society of Clinical Oncology (ASCO).

Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.

Although the coronavirus disease 2019 pandemic continues to hamper the pharmaceutical industry, it hasn’t stopped companies from continuing to make deals, seek approvals, and conclude clinical trials.

Switching patients with cancer to biosimilar pegfilgrastim for prophylaxis treatment of chemotherapy-induced febrile neutropenia could generate significant savings for adjuvant treatment, investigators found in studies presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

When used as a primary prophylaxis, biosimilar filgrastim (Zarxio) was found to be cost-effective when used to treat patients with nonmetastatic non–small cell lung cancer (NSCLC), according to a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).