Search Results for: BIOSIMILARS The US Biosimilar Approval
Articles
BIOSIMILAR DEVELOPMENT - Approval of Biosimilar Medicines Through Totality of the Evidence June 4, 2019
Hillel Cohen, PhD, outlines the evolution of biosimilar approvals and describes the process of analytical and clinical testing followed in the development of a biosimilar, with use of data from the scientific literature.
Skyrizi Approval in Japan Crucial for AbbVie as Biosimilar Competition Looms Large on Humira March 29, 2019
At a time when pricing and reimbursement pressure is mounting on its blockbuster RA drug Humira (adalimumab) in the US...AbbVie’s Immunology Pipeline Will Protect it From Biosimilar Erosion February 1, 2019
Although AbbVie is feeling the impact of Humira biosimilar launch in Europe, its strong immunology pipeline is likely to protect its hold on the plaque psoriasis (PsO) and rheumatoid arthritis (RA) markets, according to GlobalData, a leading data and analytics company.
Sandoz Proposed Biosimilar Accepted for Review by FDA September 18, 2017
Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced today that the US FDA has accepted...Cinfa Biotech Announces Positive Data for Biosimilar Candidate May 19, 2017
Cinfa Biotech S.L., the biosimilars company of Cinfa Group, recently announced positive top-line data from the second clinical trial with...Baxalta & Momenta Announce Initiation of Pivotal Clinical Trial for Biosimilar October 8, 2015
Baxalta Incorporated and Momenta Pharmaceuticals, Inc. recently announced the initiation of a pivotal clinical trial in patients with chronic plaque...Ease the Path To Biosimilars Approval April 29, 2015
Biosimilars Market Exploding! Do You Know FDA Requirements? Successful 351(k) Biosimilar Applications When it comes to FDA approval for biosimilars,...US Rheumatoid Arthritis Treatment Market Value to Reach $9.3 Billion April 1, 2015
The US treatment market for Rheumatoid Arthritis (RA) is set to increase in value from $6.4 billion in 2013 to...Opportunities Galore in Biosimilars Industry March 13, 2015
BCC Research reveals in its new report on biosimilars, the development of biotherapeutics through the use of advanced technology has...SPECIAL FEATURE- Analytical Testing of Biologics & Biosimilars March 5, 2014
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
MARKET BRIEF - Latin America Next-Generation Biosimilars Market: Opportunities & Future Growth March 4, 2014
Lucila Rocca, Healthcare Industry Analyst, Frost & Sullivan, indicates the Latin American Biosimilars market will grow at a significant rate in the next 5 years, and the importance of establishing rigorous regulation will stimulate this market growth.
Baxter International & Coherus Biosciences Sign $246-Million Pact September 9, 2013
Baxter International Inc. and Coherus Biosciences, Inc. recently announced they have entered into an exclusive collaboration to develop and commercialize...Biosimilars Market Expected to Soar February 17, 2013
Top representatives from the healthcare industry were confirmed to attend the 2nd Biosimilars Congregation which took place in London...SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution April 30, 2024
Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.
SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs January 29, 2024
Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.
Coya Therapeutics & Dr. Reddy’s Laboratories Enter Development & Commercialization Agreement for ALS Treatment December 11, 2023
Dr. Reddy’s Laboratories SA and Coya Therapeutics, Inc. recently announced they have entered into a development and license agreement for the development and commercialization of COYA 302, an investigational combination therapy for….
IMMUNOLOGY - Innovation Gathers Momentum Amid New Scientific & Technological Breakthroughs May 1, 2023
Patrick Larcier, PhD, says research is entering a new era in immunology with treatments for pathologies that previously had few or no options and looks at the latest trends and what is on the horizon for 2023 and beyond.
Bora Pharmaceuticals & Celltrion Partner to Expand OSD Capabilities in APAC Market April 5, 2023
Bora Pharmaceuticals Co., Ltd. and Celltrion Asia Pacific Pte., Ltd. recently announced their partnership to contract manufacture and commercialize a range of oral dosage form drugs (OSD) across the APAC region…..
Pfizer Invests $43 Billion in Seagen Acquisition to Battle Cancer March 14, 2023
Pfizer Inc. and Seagen Inc. recently announced they have entered into a definitive merger agreement under which Pfizer will acquire Seagen, a global biotechnology company that discovers, develops, and commercializes transformative cancer medicines, for $229 in cash….
