Biosimilar Development News

1. Teva And Alvotech Announce Strategic Partnership To Collaborate In The U.S. Biosimilar Market 8/5/2020

   Teva Pharmaceutical Industries Ltd. and biopharmaceutical company Alvotech today announced that they have entered into an exclusive strategic partnership for the commercialization in the U.S. of five biosimilar product candidates.

2. COVID-19 Impacts: Biosimilar Monoclonal Antibodies (mAbs) Market Will Accelerate At A CAGR Of Over 30% Through 2020-2024|Increase In Prevalence Of Chronic Diseases To Boost Growth| Technavio 8/4/2020

   Technavio has been monitoring the biosimilar monoclonal antibodies (mAbs) market and it is poised to grow by USD 8.65 billion during 2020-2024, progressing at a CAGR of over 30% during the forecast period.

3. SC Remsima Will Need Cost-Effective Pricing To Further Erode The Shares Of Remicade, Says GlobalData 8/4/2020

   Following the news that the first subcutaneous (SC) formulation of Celltrion’s Remsima (infliximab-dyyb/CT-P13) was granted marketing authorization by the European Commission (EC) for all indications in adults for which the intravenous formulation is also approved^*, GlobalData notes that, in order for Celltrion to further erode market share of its rival Remicade - and other anti-TNF agents in Europe, it will have to be priced intelligently as cost effective biologics are favoured by payers and regulators in this region.

4. ICYMI: Experts Detail How Shared Savings Model For Biosimilars Could Provide Savings For Seniors, Patients And Medicare 7/31/2020

   As a shared savings model gains bipartisan traction among politicians, experts continue to tout the billions of dollars of savings potential for seniors, patients and Medicare. In a recent analysis, Alex Brill, Founder of Matrix Global Advisors (MGA), an economic consulting firm, and a Resident Fellow at American Enterprise Institute, found that a robust biosimilars market could save U.S. taxpayers billions annually.

5. Biocon And Voluntis Deal Aims To Personalize Treatment For Type 2 Diabetic Patients On Insulin, Says GlobalData 7/30/2020

   Biocon Sdn. Bhd., Malaysia, a subsidiary of Biocon Biologics, and digital therapeutics company Voluntis have recently announced a global collaboration agreement to develop and distribute FDA-cleared and CE-marked digital therapeutic product ‘Insulia’ for type 2 diabetes (T2D) patients across several markets.

6. Cadila Pharmaceuticals Launches Biosimilar Rituximab Drug Ritucad 7/29/2020

   Ahmedabad-based Cadila Pharmaceuticals Limited recently announced the launch of biosimilar Rituximab for Indian market. Biosimilar Rituximab is used for treatment of blood cancer and rheumatoid arthritis, and will be launched under the brand name Ritucad.

7. Henlius And Accord Healthcare Receive EMA Approval For Zercepac, trastuzumab Biosimilar 7/29/2020

   Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) jointly announced the European Commission (EC) has approved Zercepac(HLX02), a trastuzumab biosimilar developed and manufactured by Henlius, for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

8. Centus Biotherapeutics Announces Positive CHMP Opinion For FKB238, Biosimilar Bevacizumab 7/27/2020

   Centus Biotherapeutics Ltd., a joint venture between Fujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca PLC, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of Equidacent (Product Code: FKB238), the company’s biosimilar to Avastin (bevacizumab), for indications including metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, persistent, recurrent, or metastatic carcinoma of the cervix.

9. European Commission Grants Marketing Authorisation For World’s First Subcutaneous Formulation Of Infliximab, Remsima SC, For An Additional Five Indications Including For Use In Inflammatory Bowel Disease And Ankylosing Spondylitis 7/27/2020

   Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

10. Trump Administration’s Drug Plan Must Include Biosimilars To Lower Costs For Seniors And Medicare 7/24/2020

    As the White House considers executive orders today on drug pricing, the Biosimilars Forum calls on the Trump Administration to deliver immediate savings by promoting competition, increasing access to biosimilar medications, and encouraging physicians to prescribe lower-cost biosimilars.