Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab

17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...

Read more →

Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application

2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...

Read more →

Experts expect to see “second wave” of biosimilars approvals

2 June 2021 - Experts expect to see a second wave of biosimilar approvals, though continued Medicare Part D reimbursement challenges ...

Read more →

Biosimilar bevacizumab on the PBS - information for health professionals and patients

21 May 2021 - A biosimilar brand of bevacizumab (Mvasi) will be listed on the PBS on 1 June 2021. Information ...

Read more →

Quebec announces intention to implement a biosimilar switching policy

18 May 2021 - Biosimilars Canada today congratulated the Government of Quebec and Minister of Health and Social Services Christian ...

Read more →

Sandoz Canada congratulates the Quebec government on implementing a shift towards biosimilars

18 May 2021 - The shift announced by Quebec will follow a similar approach to policies introduced in British Columbia, Alberta ...

Read more →

Sandoz Canada launches its 6th biosimilar with Inclunox and Inclunox HP (enoxaparin sodium solution for injection 100 mg/mL and 150 mg/mL (high potency))

17 May 2021 - New Sandoz biosimilar launch can potentially lower healthcare costs, especially for Canadian hospitals, as 75% of the ...

Read more →

US Supreme Court denies Sandoz petition to review biosimilar Erelzi (etanercept-szzs) case

17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...

Read more →

US, EU regulators discuss tailoring biosimilar approvals

11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...

Read more →

Alberta, Canada, begins mandating switches from originator to biosimilar Humira

6 May 2021 - Alberta, Canada becomes the latest province to begin switching patients from originator adalimumab (Humira) to biosimilar ...

Read more →

The difference between an interchangeable biosimilar and one that isn't

5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...

Read more →

Toothful or toothless? Biden's biosimilar bills under the microscope

28 April 2021 - How much muscle did Congress invest in a pair of bills recently signed by President Biden? ...

Read more →

Valeo Pharma’s Redesca and Redesca HP to be covered under the Ontario Public Drug Benefit Program

28 April 2021 - Additional provincial coverage expected to follow. ...

Read more →

New Brunswick becomes third province in Canada to implement biosimilar switching policy

21 April 2021 - Biosimilars Canada today congratulated the Government of New Brunswick for implementing a biosimilar "switching" or transitioning ...

Read more →

Samsung Bioepis continues global market expansion with launch of Hadlima in Australia and Canada in partnership with Merck

29 March 2021 - Samsung Bioepis’ adalimumab is now available in three markets: Europe, Canada and Australia. ...

Read more →