biosimilars
[Industry Update] The changing biosimilars landscape in Latin America
June 04 by Pharma IQTTY Biopharma and the Mexican Pharmaceutical Institute share their insight on regulatory and market changes in Latin America around biosimilars
Market Snapshot - Top 10 Biosimilars Manufacturers 2015
May 28 by Pharmaceuticals & Biotechnology EditorWith the approval of the first biosimilar product in the United States this year, cost containment pressures and a pending patent cliff, Pharma IQ takes a closer look at the current biosimilars mark...
Newly Published Draft Guideline on Similar Biological Medicinal Products
May 01 by Pharma IQThe European Medicines Agency (EMA) published draft guidelines today, 2nd May 2013 on Similar Biological Medicinal Products. The guideline outlines the general principles to be applied for s...
Pharma & Outsourcing Practice: Biosimilars - Guidelines, Players, Providers
June 01 by Pharmaceuticals & Biotechnology EditorIN THIS ISSUE: Outsourcing for biosimilars Approvals and guidance Biosimilar monoclonal antibodies Players and their responsibility Service Providers GET THE COMPLETE REPORT...
Biosimilars Landscape and FDA Regulatory Expectations
March 21 by James HarrisThe Congressional Budget Office (CBO) has estimated that the United States could save $25 billion from the use of biosimilars over 10 years. In a general sense the term biosimilars refers to fo...
Biosimilars: Prioritising the Emerging Market Opportunity
September 01 by Pharmaceuticals & Biotechnology EditorBy 2015, approximately USD73 billion of biologic sales are projected to lose patent protection, opening the door for the entry of biosimilar versions of these agents. The majority of agents losing p...
Global Biosimilars Outlook 2011
August 25 by Pharma IQ“I think it’s fair to say that we expect in the 2015 to 2020 period, biosimilars will see a high rate of growth and share of the market.” Murray Aitken, Executive Director, IMS Institute for Healthcar...
FDA to Issue Guidance on the Biosimilar Pathway by End of 2011
May 17 by Pharma IQIt was only matter of time before the United States Food and Drug Administration (FDA) put in place guidance for the marketing of biosimiliars – and it would seem that time is almost upon us. Global...
Realising the Demand for Affordable Healthcare: Opportunities and Challenges
May 11 by Pharma IQAsia looks to be at the forefront of growth within the pharmaceutical industry in the next few years, particularly the emerging markets of India and China. Costs of drug development in the region...
FDA to Address Industry Questions about Biosimilar Regulations at the Pharma's IQ Immunogenicity Event
April 04 by Pharma IQ NewsThis May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's Immunogenicity event to discuss FDA directives on Immu...
Case Study: Design Space Development for Large Molecules in Upstream Processing Concept
October 19 by Pharmaceuticals & Biotechnology EditorWhat are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out!
Challenges and Changes in Bioequivalence Studies
August 15 by Pharma IQHelmut Schutz, CEO of BEBAC, joins Helen Winsor from Pharma IQ, to talk about the challenge of sample sizes in bioequivalence studies. The interview explores the idea of literature data versus pilot s...