Biosimilar trastuzumab and rituximab on the PBS - information for health professionals and patients

2 January 2019 - New biosimilar brands of trastuzumab (Ontruzant) and rituximab (Truxima) have listed on the PBS on 1 January ...

Read more →

Amgen and Allergan submit biologics license application for ABP 798, biosimilar candidate to Rituxan (rituximab), to U.S. FDA

19 December 2019 - Filing for ABP 798 supported by two comparative clinical studies. ...

Read more →

Statement from Anna Abram, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on low-cost biosimilar and interchangeable protein products

17 December 2019 - Ensuring an efficient pathway to bring potentially lower-cost biosimilar and interchangeable protein products to market is ...

Read more →

Alberta changes coverage of biologic drugs for people with Crohn's, diabetes, arthritis

12 December 2019 - The provincial government says will free up hundreds of millions of dollars in health funding during the ...

Read more →

Canadian study shows substantial savings possible with use of biosimilar filgrastim

12 December 2019 - During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar ...

Read more →

Alberta will force patients to switch from biologics to cheaper biosimilar medications

12 December 2019 - Alberta will force 26,000 patients on government-sponsored drug plans to switch from expensive drugs that are known ...

Read more →

Biosimilar stakeholders praise removal of biologic exclusivity provisions from USMCA

11 December 2019 - An agreement on the United States–Mexico–Canada Agreement, a trade deal that updates the North American Free ...

Read more →

FDA approves Amgen's Avsola (infliximab-axxq), for the same indications as Remicade (infliximab)

6 December 2019 - Amgen's fourth FDA approval from biosimilars portfolio. ...

Read more →

Is it time to look beyond price with biosimilars?

5 December 2019 - While there is no question that falling prices that come with competition are cause for optimism in ...

Read more →

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

2 December 2019 - A new biosimilar brand of trastuzumab (Kanjinti) has listed on the PBS on 1 December 2019.  ...

Read more →

Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis

25 November 2019 - European Union marketing approval is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety ...

Read more →

Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

25 November 2019 - Access to affordable insulin can be a matter of life and death for Americans with diabetes.  ...

Read more →

FDA accepts Samsung Bioepis’ BLA for SB8 bevacizumab biosimilar candidate

19 November 2019 - Samsung Bioepis today announced that the U.S. FDA has accepted for review the company’s biologics license ...

Read more →

Biosimilars make progress in the Canadian market, but stakeholders see more work ahead

18 November 2019 - While much attention over the past few weeks has been on the US biosimilars market, with its ...

Read more →

FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions

18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira ...

Read more →