High Quality Biosimilars
Improving Global Healthcare Access
Target Biosimilars is a biotechnology company focused on improving global healthcare access through the development of high quality biosimilars.
The company’s mission is to reduce healthcare costs and expand patient access to biologic therapies in markets where biosimilars remain limited.
Extensive regulatory, clinical, & manufacturing experience
The founding team brings extensive regulatory, clinical, and manufacturing experience, including previous roles at organisations such as the MHRA and Samsung Biologics.
Target Biosimilars integrates GMP manufacturing, regulatory strategy and biosimilar development expertise to deliver reliable, high quality biologic medicines.
Keith Watson, PhD
Chief Executive Officer
Keith Watson is an ex-regulator with 30 years of experience in academia, manufacturing, development, regulation, consultancy and regulatory policy environments.
This has been gained from working at a tier one CMDO, as a quality assessor at the MHRA, being EU Practice lead for CMC at a global CRO and senior regulatory, policy and strategy positions in small to medium sized pharma and/or biotech Companies.
Biologics Expert
Whilst at the MHRA, Keith was an active participant in UK’s Biologics and Vaccines Expert Advisory Group (BVEAG) and Committee for Human Medicines (CHM) as well their European counterparts, Biologics Working Party (BWP), and Committee for Human Medicinal Products (CHMP).
Extensive Experience
Keith has reviewed and compiled multiple marketing authorizations and also participated or led over 100 scientific advices with National and Regional regulatory bodies (UK, EMA, FDA, TGA, ANVISA amongst others). He has a thorough understanding of the scientific advice and marketing authorization procedures and used to developing questions, positions and scientific arguments to convince the regulator to support innovative solutions.
Keith has been part of various CHMP working parties and contributed to multiple guidelines and working parties such as those related to monoclonal antibodies, plasma derived products, plasma master files, biosimilars, vCJD and TSE. Keith also has extensive regulatory policy experience and over the last 8 years has been a pro-active contributor to various working and sub-groups of EFPIA (CMC, TDEG, Orphan designation), IFPMA (Bio-therapeutics, GMP and CMC), Medicines for Europe (biosimilars, medical devices) IGBA (ICH EWG On revision to M4Q) and EuropaBio (Biosimilars).
The inside knowledge of the policy environment, not only provides us with access to key regulatory stakeholders, it also enables us to educate our clients on key regulatory agency policy initiatives and navigate them to position papers and information that could assist them in their development.
Anthony Newcombe, PhD
Chief Operating Officer
Target Biosimilars is co-founded by Dr Anthony Newcombe, a biologics regulatory CMC and compliance expert with over 25 years of experience in development, GMP manufacturing, regulatory CMC, auditing and compliance.
Anthony’s background includes senior operational and quality leadership roles in global pharmaceutical and biotechnology organisations including GSK, Pfizer and Samsung Biologics. His experience covers biologics, vaccines, antibody-drug conjugates (ADCs) and advanced therapy medicinal products (ATMPs), with a focus on building compliant and efficient GMP manufacturing operations that meet EU, FDA and global regulatory expectations.
Biologics Expert
Anthony has held executive leadership roles with responsibility for global CMC, GMP manufacturing and quality operations across multiple international organisations. At Samsung Biologics, he was part of the site leadership team overseeing technology transfers and GMP manufacturing at the world’s largest monoclonal antibody production facility. He has also provided strategic oversight to support the development and regulatory approval of several biologics, including the first biosimilar monoclonal antibody approved in the European Union and the first FDA approved autologous cell therapy.
Global Experience
Anthony has held senior operational and quality leadership roles including Chief Operating Officer at VectorY Therapeutics, Senior Director of CMC & Programme Management at Samsung Biologics and Senior Vice President of Manufacturing at POLUS Inc. He has managed large-scale biologics and biosimilar manufacturing operations and led technology transfers to support global GMP compliance.
His regulatory experience includes participation in inspections and scientific advice meetings with agencies such as the FDA and EMA. Anthony holds a PhD in Biochemistry from the MRC National Institute for Medical Research in London and has authored more than 30 scientific and technical publications.
With a career spanning biopharmaceutical development, GMP compliance and manufacturing operations, Anthony brings extensive operational and strategic experience to Target Biosimilars’ mission of developing high-quality, accessible biosimilar medicines through scientific excellence and global manufacturing expertise.
High Quality Biosimilars, Expanding Global Access
Cost Effective Biologics, Growth Opportunities
Target Biosimilars is a biotechnology company developing high quality biosimilars to expand global access to biologic medicines. Leveraging regulatory, clinical and manufacturing expertise, the company aims to deliver cost effective biologics and capture growth opportunities in markets with unmet demand for targeted biosimilars.
Chief Operating Officer, Target Biosimilars
Anthony Newcombe, PhD
Target Biosimilars is co-founded by Dr Anthony Newcombe, a biologics regulatory CMC and compliance expert with over 25 years of experience in development, GMP manufacturing, regulatory CMC, auditing and compliance.
Anthony’s background includes senior operational and quality leadership roles in global pharmaceutical and biotechnology organisations including GSK, Pfizer and Samsung Biologics. His experience covers biologics, vaccines, antibody-drug conjugates (ADCs) and advanced therapy medicinal products (ATMPs), with a focus on building compliant and efficient GMP manufacturing operations that meet EU, FDA and global regulatory expectations.
Biologics Expert
Anthony has held executive leadership roles with responsibility for global CMC, GMP manufacturing and quality operations across multiple international organisations. At Samsung Biologics, he was part of the site leadership team overseeing technology transfers and GMP manufacturing at the world’s largest monoclonal antibody production facility. He has also provided strategic oversight to support the development and regulatory approval of several biologics, including the first biosimilar monoclonal antibody approved in the European Union and the first FDA approved autologous cell therapy.
Extensive Global Experience
Anthony has held senior operational and quality leadership roles including Chief Operating Officer at VectorY Therapeutics, Senior Director of CMC & Programme Management at Samsung Biologics and Senior Vice President of Manufacturing at POLUS Inc. He has managed large-scale biologics and biosimilar manufacturing operations and led technology transfers to support global GMP compliance.
His regulatory experience includes participation in inspections and scientific advice meetings with agencies such as the FDA and EMA. Anthony holds a PhD in Biochemistry from the MRC National Institute for Medical Research in London and has authored more than 30 scientific and technical publications.
With a career spanning biopharmaceutical development, GMP compliance and manufacturing operations, Anthony brings extensive operational and strategic experience to Target Biosimilars’ mission of developing high-quality, accessible biosimilar medicines through scientific excellence and global manufacturing expertise
