Skylar Jeremias

Despite there being concerns over the safety of nonmedical switching between a reference product and a biosimilar, there is a growing body of evidence supporting the safety of switching, according to an executive of Sandoz, which produces biosimilars.

A joint venture between Fujifilm Kyowa Kirin Biologics and AstraZeneca has received a positive biosimilar opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Phase 3b trial results presented at American Academy of Dermatology Virtual Meeting Experience 2020 confirmed that Boehringer Ingelheim (BI)’s adalimumab biosimilar candidate is comparable to that of the reference product.

President Trump signed 4 executive orders that would lower prices of prescriptions medications including insulin products and cancer medicines.

Cadila Pharmaceuticals has launched a bevacizumab biosimilar referencing Avastin in India. Bevacizumab is used for the treatment of colorectal, breast, and lung cancers, among others.

As capacity at its 3 existing plants begins to run out, Samsung Biologics will add a fourth plant to its Incheon, Republic of Korea, site.

China-based Bio-Thera Solutions is breaking into the growing Russian biosimilar market by licensing the marketing rights for its unapproved golimumab biosimilar to Russian biopharmaceutical company Pharmapark.

Polpharma Biologics said it is close to finishing its integration of Bioceros, a company it acquired 4 years ago. The acquisition gave Polpharma an advanced cell line development platform, and with a bioreactor facility nearing completion, the company said it is poised for growth.

Here is a collection of some of our most recent clinical trial news articles.

The Generic and Biosimilar Medicines Association in Australia reported its 2020 Biosimilar Awareness Week was successful, with educational messages from the event reaching over 540,000 Australians via social media.

Wui-Jin Koh, senior vice president and chief medical officer of the National Comprehensive Cancer Network (NCCN) laid out the current initiatives that organization has taken to promote the use of biosimilars in oncology settings.

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.