Business

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.

Shanghai Henlius Biotech has been given the green light to market its trastuzumab biosimilar (Zercepac, HLX02) in the European Union. Accord Healthcare will handle the distribution.

If you can’t beat biosimilars, join them, is the mantra; but at Amgen there’s still gold in originator products, according to its latest earnings report.

Biologics are not cheap, and if you can get biosimilars into the hands of patients, you’ve got something going. A strategist describes the step-by-step process that made this possible at Kaiser Permanente.

Although more advanced than in the United States, biosimilars markets in Europe may discourage competition over the long term, said officials from Medicines for Europe.

While Amgen fends off etanercept biosimilar competition in the United States, Pfizer said it is facing a mounting battle against biosimilar competition in European and other markets.

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.

For Biocon, overall revenues were up during the fiscal quarter that just ended, driven by strong revenues in its biosimilars and generics operations.

The company saw a 7% decline in biosimilar revenues in the second quarter of 2020 compared with the same quarter in 2019.

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.

Biosimilar misinformation takes many forms, some of it institutionalized in the form of word usage and some of it deliberately disparaging, 2 executives of Sandoz and Boehringer Ingelheim contend.

A panel of experts discusses the ways in which payers restrict prescribing choices for physicians and what that means for the future of biosimilar utilization.

The Center for Biosimilars® interviewed Anurag S. Rathore, PhD, whose team of investigators evaluated why applications for biosimilar approvals do not succeed. Large companies as well as small find the approval process challenging, but there is a learning curve that may be followed by more consistent approvals, he explains.

In a webinar this week, experts discussed the business dynamics that prevent providers from being able to choose the lowest-cost biosimilars.

With insulin originator product patents expiring, drug companies are seeking to extend exclusivities via patents on injectors and other delivery products.

As part of a project to build the first biosimilar factory in Malaysia, one of the initial products would be halal certified.

We sat down with Byoungseo Choi, the head of marketing for Celltrion Healthcare, to discuss exactly how this plan is going to work, the company’s current biosimilar pipeline, and its expectations for how their products will perform.

Investigators found that process complexities have created numerous difficulties for biosimilar developers in regulatory filings, but they anticipate that the success rate will improve with experience and improved guidance.

Byoungseo Choi, head of marketing for Celltrion Healthcare, discusses Celltrion’s biosimilar pipeline, the competitive landscape for its products, and its plans to build a biosimilar production center in Wuhan, China.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.

The rise of biologics as a class of prescription spending is fueling a trend toward longer exclusivity periods, which ultimately makes access more remote, authors of a new study said.

Byoungseo Choi, head of marketing for Celltrion Healthcare, discusses how Celltrion's infliximab biosimilar can aid in the treatment of coronavirus disease 2019 (COVID-19)–related inflammation, as well as the company’s launch plans for biosimilars through 2030.

In court filings this week, Genentech and Amgen laid to rest their long-running dispute over the marketing of bevacizumab and trastuzumab biosimilars that challenged Genentech's dominance of the market for those products.

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.

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

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.

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.