pharmabio consulting


Biosimilars Service

PHARMABIO Consulting excels in the development of BIOSIMILAR MEDICINES, staff having led some of the first biosimilars approvals on the EU market 2006-2016 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 Abbreviated-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 and Protocol Assistance from CHMP/EMA
Scientific Advice and Protocol Assistance from CHMP/EMA; SAWP/CHMP/EMA meetings

Rehearsing for FDA meetings; managing FDA meetings

Biosimilars User Fee Act (BsUFA) US FDA meetings and NDA (b2)/ABLA (351k) presubmission FDA meetings, MAA presubmission EU EMA meetings, MAA presubmission EU Rapporteur/Co-rapporteur meetings, Rapporteur/Co-rapporteur D120 and D180 EU Clarification meetings

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

Hoss has published 5 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 broadcasts to US and EU monthly thought leadership professional webinars 2011-2016 and present:
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.

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.

The opportunities and challenges of biosimilar orphans (editorial), Expert Opinion on Orphan Drugs (Informa publishers), April 2016.

Current 2016 biosimilars articles by Hoss A Dowlat:
Interchangeability among reference insulins and their biosimilars: regulatory framework, study design, and clinical implications
The opportunities and challenges of biosimilar orphan drugs and non-orphan but rare disease indications.

Your experts in Drug Development and Global Regulatory Affairs.