Samsung Bioepis, a developer of biosimilars and new drugs, announced the interim results of its Phase 1 and Phase 3 clinical ...

GUANGZHOU, China--(BUSINESS WIRE)--Bio-Thera Solutions (688177.SS), a commercial-stage biopharmaceutical company, today announced that dosing has begun in a Phase I clinical study to compare the ...

As increasing numbers of highly-successful biologics come off patent, biosimilars are a promising area for investment, offering growth potential that is lacking in many other areas of the biopharma ...

Currently, the global biosimilars market includes monoclonal antibody (mAb) biosimilars, insulins, interferons, erythropoietins, filgrastim, somatropin and follicle-stimulating hormone. Of these, the ...

In Canada, biosimilar products are approved by way of a new drug submission, following Health Canada guidance first released ...

The Trump administration’s latest effort to lower drug costs is expanding to biosimilars, medications that are highly similar to biologic drugs made with or isolated from living organisms such as ...

Patent litigation reform could accelerate US biosimilar market entry, which lags behind the EU due to protracted legal processes. Biosimilar manufacturers face options like pre-clearance, "at-risk" ...

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs which includes numerous proposed revisions ...

The biosimilar SB4 produced response rates equivalent to those associated with etanercept (ETN; Enbrel, Amgen) in patients with severe rheumatoid arthritis (RA) whose disease was not controlled by ...

Samsung Epis Holdings subsidiary Samsung Bioepis said on the 29th that SB27, a candidate biosimilar to the immuno-oncology drug "Keytruda (ingredient name pembrolizumab)," met its primary endpoints in ...