Biosimilar Development News

1. Crohn’s And Colitis Canada Response To Alberta Non-Medical Switch Policy
   12/12/2019
2. Biosimilars Forum Statement On Policies Supporting Biosimilar Uptake In Canadian Market
   12/12/2019

   The Biosimilars Forum released the following statement after the Canadian province of Alberta announced that it will switch patients on government-sponsored health plans from using more expensive biologics to using lower-cost biosimilars.

3. Alberta’s Biosimilars Policy: Another Significant Step Towards Improving Patient Access To Safe, Effective, And High-Quality Medicines In Canada
   12/12/2019

   Sandoz Canada today welcomes Alberta Health’s switch policy announcement on biosimilars.

4. AffaMed Therapeutics Receives NMPA Approval To Initiate Phase III Clinical Trial In China With Herceptin® (Trastuzumab) Biosimilar Candidate AMT901
   12/10/2019

   AffaMed Therapeutics, a biopharmaceutical company founded and funded by CBC Group, a healthcare private equity firm focused on the development and late-stage investment opportunities, today announced it has received Clinical Trial Application (CTA) approval from the China National Medical Products Administration (NMPA) to conduct clinical trials for AMT901, or SB3, a biosimilar for Herceptin® (trastuzumab).

5. PharmaForce International: Post-Approval Biosimilar Drugs Encounter Obstacles When Entering Into The US Market
   12/10/2019

   PharmaForce International's recent syndicated report benchmarks leading Biosimilar sales and marketing organizations in the United States. This study profiles various biosimilar products competing in high-demand markets such as Oncology, Immunology, and Diabetes. One key finding is the delay of select biosimilar products in entering the vastly competitive market.

6. FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab)
   12/6/2019

   Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS).

7. Biosimilars Market Growth To Upsurge Due To Enhanced Demand From Pharmaceutical Companies Till 2025 | Million Insights
   12/6/2019
8. NeuClone Announces Positive Results From Phase I Study Of Herceptin (Trastuzumab) Biosimilar Candidate
   12/5/2019

   NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced that NeuCeptin, a biosimilar candidate of Herceptin (trastuzumab), has successfully met all primary and secondary endpoints in a Phase I clinical trial. 

9. NeuClone Announce Positive Results From Phase I Study Of Herceptin (Trastuzumab) Biosimilar Candidate
   12/5/2019

   NeuClone Pharmaceuticals Ltd (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced that NeuCeptin, a biosimilar candidate of Herceptin (trastuzumab), has successfully met all primary and secondary endpoints in a Phase I clinical trial.

10. Lannett Announces Positive Results From Human Clinical Trial Of Biosimilar Insulin Glargine Versus US Lantus®
    12/5/2019

    Lannett Company, Inc. (NYSE: LCI) today announced positive results from the first human study evaluating insulin glargine that Lannett is developing with its strategic alliance partners within the HEC Group of companies (HEC).