Biosimilar

One Day Online Seminar on Understanding Latin America's Regulatory Compliance Requirements Across the Life Science Industry: Pharmaceuticals, Biologics, Medical Devices, IVDs - October 6th, 2021 - ResearchAndMarkets.com

Friday, June 11, 2021 - 1:55pm

The "Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)" training has been added to ResearchAndMarkets.com's offering.
  • The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
  • This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, IVDs, Biologics, Biosimilars, Orphan Drugs and Combination Products in Latin America.
  • Beginning Your Company Involvement in Latin America: Examples of Country Requirements
    Marketing Authorization Process & Dossier Requirements: Pharmaceuticals

Adalimumab Biosimilar Market Insight Report 2021 - ResearchAndMarkets.com

Thursday, June 10, 2021 - 1:32pm

The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Adalimumab - Biosimilar Insight, 2020" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Adalimumab- Biosimilar Insight, 2021," report provides comprehensive insights about 35+ companies and 35+ marketed and pipeline drugs in Adalimumab Biosimilars landscape.
  • Abrilada is an FDA-approved biosimilar version of adalimumab.
  • Bio-Thera Solutions has received approval from the country's National Medical Products Administration (NMPA) for Qletli, a biosimilar to AbbVie's Humira (adalimumab).

iBio Further Strengthens Board with Appointment of Veteran Biopharmaceutical Executive, Eef Schimmelpennink

Wednesday, June 9, 2021 - 9:30pm

BRYAN, Texas, June 09, 2021 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (iBio or the Company), a biotech innovator and biologics contract manufacturing organization, announced today the appointment of Evert (Eef) Schimmelpennink to its Board of Directors, effective immediately.

Key Points: 
  • BRYAN, Texas, June 09, 2021 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) (iBio or the Company), a biotech innovator and biologics contract manufacturing organization, announced today the appointment of Evert (Eef) Schimmelpennink to its Board of Directors, effective immediately.
  • Pfenex was acquired by Ligand Pharmaceuticals Incorporated for approximately $516 million (including contingent value rights) in October 2020.
  • Previously, Mr. Schimmelpennink served as CEO of Alvotech Ehf, a global biopharmaceutical company focused on becoming a leader in the biosimilar monoclonal antibody market.
  • Eef has a strong history of success leading companies with novel protein expression platforms to develop and commercialize biopharmaceutical products, said Tom Isett, Chairman & CEO of iBio.

Magellan Rx Management Oncology Biosimilar Solution Delivers $40M+ in Annualized Savings for Early Adopter Health Plans

Wednesday, June 9, 2021 - 11:30am

Magellan Rx Management , a division of Magellan Health, Inc. (NASDAQ: MGLN), today announced annualized savings of over $40 million for five health plan customers who were early adopters of its oncology biosimilar medical benefit drug management solution .

Key Points: 
  • Magellan Rx Management , a division of Magellan Health, Inc. (NASDAQ: MGLN), today announced annualized savings of over $40 million for five health plan customers who were early adopters of its oncology biosimilar medical benefit drug management solution .
  • Health plans can leverage the extensive clinical expertise and experience at Magellan Rx by delegating specialty and medical drug management services while retaining a separate PBM.
  • To learn more about Magellan Rx Managements history of biosimilar management, visit, Magellan Insights.
  • About Magellan Rx Management: Magellan Rx Management , a division of Magellan Health, Inc. , is a next-generation pharmacy organization that is delivering meaningful solutions to the people we serve.

Bio-Thera Solutions Initiates Phase III Clinical Trial for BAT2506, a Proposed Biosimilar of Simponi® (Golimumab)

Tuesday, June 8, 2021 - 1:08pm

Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).

Key Points: 
  • Bio-Thera Solutions, Ltd. (688177.SH), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase III clinical study for BAT2506, a proposed biosimilar of Simponi (golimumab).
  • Patient enrollment in our Phase III clinical trial for BAT2506 is another important achievement for Bio-Thera as it is our third proposed biosimilar to enter a global Phase 3 study, said Shengfeng Li, CEO, Bio-Thera Solutions.
  • Bio-Thera Solutions is developing several additional proposed biosimilars, including a bevacizumab biosimilar and a tocilizumab biosimilar that have both successfully completed global Phase III clinical trials.
  • 2 QLETLI is a registered trademark of Bio-Thera Solutions, Ltd.
    3 is a registered trademark of Bio-Thera Solutions, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210608005454/en/

World Rheumatoid Arthritis (RA) Disease Analysis and Market Report 2020-2025: Spearheaded by Humira and Enbrel, the anti-TNF Class will Remain Dominant, Despite Pressure from Biosimilars - ResearchAndMarkets.com

Friday, June 4, 2021 - 10:08am

The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition.

Key Points: 
  • The rheumatoid arthritis (RA) market is set to experience increasing attrition due to biosimilar competition.
  • The EU market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance of biosimilars compared to other countries.
  • As multi-billion-dollar products, Humira and Enbrel represent the best-selling brands in the market, and their stronghold will continue.
  • AbbVie's experience and presence in the RA market will foster success for the drug, despite its third-to-market status.

Organon Launches as New Women’s Health Company

Thursday, June 3, 2021 - 5:30am

This will be fueled by a refreshed focus on our womens health portfolio, further biosimilar launches, and a renewed energy put behind our trusted dermatology, pain, respiratory and cardiovascular brands.

Key Points: 
  • This will be fueled by a refreshed focus on our womens health portfolio, further biosimilar launches, and a renewed energy put behind our trusted dermatology, pain, respiratory and cardiovascular brands.
  • Our strength will come not only from our medicines and solutions but from the diverse team of Organon Founders we have gathered to launch this unique company.
  • Organon (NYSE: OGN) is a global healthcare company formed through a spinoff from Merck to focus on improving the health of women throughout their lives.
  • Here for her health, the company has a portfolio of more than 60 medicines and products across a range of therapeutic areas.

Biogen and Bio-Thera Announce Positive Results From Phase 3 Study of BAT1806, a Proposed Biosimilar Referencing Actemra® (Tocilizumab)

Tuesday, June 1, 2021 - 12:30pm

and GUANGZHOU, China, June 01, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab).

Key Points: 
  • and GUANGZHOU, China, June 01, 2021 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA/RoACTEMRA (tocilizumab).
  • Biogen has exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).
  • We are pleased to report on our third proposed biosimilar with positive Phase 3 study results.
  • These results demonstrate the potential of our proposed tocilizumab biosimilar to be a safe and effective treatment, said Shengfeng Li, Ph.D., chief executive officer at Bio-Thera Solutions.

Global Biosimilar Market (2021 to 2026) - Industry Trends, Share, Size, Growth, Opportunity and Forecasts - ResearchAndMarkets.com

Friday, May 28, 2021 - 7:13pm

The "Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biosimilar Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026" report has been added to ResearchAndMarkets.com's offering.
  • The biosimilar market reached a value of US$ 7.7 Billion in 2020.
  • Catalyzed by these factors, the market is expected to witness strong growth during the next five years.
  • For being labelled as a biosimilar, a biological drug should be proved similar in terms of quality, safety and efficacy.

BioFactura Announces Initiation of Phase I Study of BFI-751, a Stelara® (ustekinumab) Biosimilar

Tuesday, May 25, 2021 - 2:00pm

The first-in-human Phase I study initiated by BioFactura Australia Pty Ltd is a bioequivalence randomized, double-blind, trial being conducted in Australia and New Zealand.

Key Points: 
  • The first-in-human Phase I study initiated by BioFactura Australia Pty Ltd is a bioequivalence randomized, double-blind, trial being conducted in Australia and New Zealand.
  • The study will also assess the safety and tolerability of BFI-751 in 210 healthy volunteers and their immune response.
  • The initiation of this inaugural first-in-human study is an important milestone for BioFactura as it marks the beginning of clinical development of the first product candidate in our biosimilar pipeline.
  • BioFactura has targeted an addressable niche in the biosimilars market with current innovator revenues of over $25 billion.