Biosimilars
Biosimilars Service
PHARMABIO Consulting excels in the development of BIOSIMILAR MEDICINES, staff having led some of the first biosimilars approvals on the EU market 2006-2018 under Article 10(4) of Directive 2001/83/EC. It is also active in implementing the Biologics Price Competition and Innovation Act (BPCI) passed by the US Senate in 2009/2010, under a 351k BLA (Abbreviated compared to 351a BLA) pathway.
The PHARMABIO Team conducts Due Deligence of Biosimilars drug development or drug licencing candidates, pharmaceutical comparability study design, clinical study phase I and phase III comparability design, project management, and scientific and regulatory writing. This includes clinical protocol development, ICH clinical report writing, regulatory submissions, manuscripts, clinical study management, as well as technical QA and QC audits.
PHARMABIO Consulting provides expertise covering all key disciplines of Biosimilars development, having regulatory experts including former FDA and EU regulators, statisticians, clinical pharmacology and clinical efficacy/safety and pharmaceutical experienced consultants. With global strategy in mind, we can help you with a comprehensive, program for the selection, development and approval of any type of biosimilar product, anywhere in the world.
Our services for Biosimilars development include:
Comparability strategy consultations and review of chemistry, manufacturing and control, preclinical and clinical plans, with exact study designs.
Regulatory authority liaison to EMA or FDA
Scientific Advice (SA) and Protocol Assistance (PA) from CHMP/EMA; SAWP/CHMP/EMA meetings
Preparing questions and briefing packages.
Liaising with Coordinators from EMA.
Following-up SA by clarification or further SA (FUSA).
Biosimilars User Fee Act (BsUFA Type 1, 2, 3, 4) US FDA meetings
Preparing questions and briefing packages.
Arranging meetings and coordinating and liaising with FDA divisions.
Rehearsing for FDA meetings; managing and leading FDA meetings.
NDA (b2)/BLA (351k) presubmission FDA meetings, MAA presubmission EU EMA meetings, MAA presubmission EU Rapporteur/Co-rapporteur meetings, Rapporteur/Co-rapporteur D120 and D180
Responding to Major Objections (deficiencies)
EU Clarification meetings
EU Oral Hearings/Explanations
Presubmission evaluation of technical data (chemistry/manufacturing, preclinical, clinical, labeling)
Determination of regulatory and legal status
Obtaining Small and medium-sized enterprise (SME) status (as Annex to SME PharmaBio) and other financial and regulatory incentives even for companies with non-European offices
Determination of regulatory strategy for planning, manufacturing, preclinical and clinical development
Expert reports; CTD quality overall summary, non-clinical and clinical overviews and summaries
Biosimilars Risk Management Plans (RMPs)
Biosimilars Product information: EU SmPC, PL, Labels; US PI, Labels,
Document preparation including marketing authorisation applications MAAs for biosimilars
Submission of responses and follow-up to EMA MAA list of D120 and D180 Deficiency Questions, Clarification Meetings, or CHMP/EMA Oral Explanations, or to FDA NDA (b2)/ABLA Disciplinary letters
(Photos represent two of a number of 2017 and 2018 FDA PharmaBio-led biosimilars meetings at FDA Headquarters, 10903 New Hampshire Avenue, White Oak Building 22, Silver Spring, Maryland 20903, USA)
Publications on Biosimilars :
Hoss has published milestone articles on biosimilars in 2012; March (US), April (EU), May (EU), May (US) and July (US), and a RAPS book biosimilars chapter in 2013, and later in 2016-2018 (examples below). Hoss also broadcasts to US and EU monthly thought leadership professional webinars and provides lectures, seminars and trainings on Biosimilars 2011-2018 to present day (details under “PharmaBio’s Lectures and Seminars”):
Regulatory Focus, Journal of the Regulatory Affairs Professional Society (international) (RAPS):
Biosimilars Breaching Borders: How FDA and EMA Find Common Ground, March, 2012.
How Safe Are Biosimilars? Implications of FDA and EMA Guidances and European Experience since 2006, Pt 1, May; Pt 2, July 2012.
Regulatory Rapporteur, The International Journal for Professionals in Regulatory Affairs (TOPRA):
Perceptions and realities of clinical safety of biosimilars – EU and US perspectives: Pt 1, April; Pt 2, May 2012.
RAPS, Fundamentals of International Regulatory Affairs, Second Edition, Advancement of Biosimilars Development in Europe, USA, and Internationally, 2013.
A. Dowlat*, M. K. Kuhlmann, H. Khatami & F. J. Ampudia-Blasco, Interchangeability among reference insulin analogues and their biosimilars: regulatory framework, study design and clinical implications, Diabetes, Obesity and Metabolism 2016 (John Wiley & Sons Ltd). doi:10.1111/dom.12676 3.
Hoss A Dowlat, The opportunities and challenges of biosimilar orphans (editorial), Expert Opinion on Orphan Drugs (Informa publishers), April 2016. Prior to final typeprint publication: http://www.tandfonline.com/eprint/NHakDzmIvANjIj7eNjj9/full.
Ulrike Hövelmann, Leszek Nosek, Hoss A. Dowlat, Amee Mehta and Tim Heise, Solumarv, a regular human insulin, and Isomarv, a NPH-insulin preparation, show bioequivalence to EU-marketed insulins, 76th Scientific Sessions, American Diabetes Association (ADA), New Orleans, USA, June 10-14, 2016.
Hoss Dowlat, Carsten Brockmeyer, Fiona Greer, Rick Lozano, Editorial by Stephanie Sutton, I’m a (Biosimilars) Believer!, Four biosimilar gurus discuss successes and tackle the issues head on, Medicine Maker, May 2018, Issue #0518.
