11th Biosimilars Congregation 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • MAYUR PARMAR

    MAYUR PARMAR FDA

  • BINDU AJIT

    BINDU AJIT Biocon Academy

  • MILIND NARVEKAR

    MILIND NARVEKAR Teva Pharmaceuticals

  • LALIT LAKHWANI

    LALIT LAKHWANI Dr. Reddy's Laboratories

  • RAVISHANKAR KASTURI

    RAVISHANKAR KASTURI Reliance Life Sciences

  • HANMANT BARKATE

    HANMANT BARKATE Glenmark Pharmaceuticals

  • ARUN BHATT

    ARUN BHATT

  • SAMIR KULKARNI

    SAMIR KULKARNI

  • SHUBHADEEP SINHA

    SHUBHADEEP SINHA Hetero Labs

  • MANALI AGRAWAL

    MANALI AGRAWAL Bayer

  • KIRAN KALAVADIA

    KIRAN KALAVADIA Cipla

  • AMMAR RAZA

    AMMAR RAZA Allergan

  • ANIL KUKREJA

    ANIL KUKREJA Roche Pharmaceuticals

  • ANITA KRISHNAN

    ANITA KRISHNAN Lupin

  • SONIKA SHAH

    SONIKA SHAH Amgen

  • MILIND ANTANI

    MILIND ANTANI Nishith Desai Associates

  • HEMANT DHAMNE

    HEMANT DHAMNE Intas Pharmaceuticals (Biopharma Division)

  • VIJAY NAG THOTA

    VIJAY NAG THOTA SciGen BioPharma

  • ALAP GANDHI

    ALAP GANDHI Glaxo Smith Kline (GSK)

  • ROSHAN PAWAR

    ROSHAN PAWAR Alkem Laboratories

  • PRASHANT BODHE

    PRASHANT BODHE CliniSearch

06th December 2017, Kohinoor Continental Hotel, Mumbai, India

“Uniting industry leaders to analyse advanced commercial developments & to identify successful management strategies of Biosimilars”

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CONFERENCE INTRODUCTION:- 

Virtue insight is proud to present its 11th Biosimilars Congregation on 6th December 2017 in Mumbai – India. Discussing strategies for biosimilar product development Indian Pharmaceutical companies have started to look at biosimilars as a lucrative sector owing to the recent regulatory approvals and revenue generating opportunities.

Though biosimilars are less costly versions of the biologics, their development is much more complex, this makes their regulatory approval more difficult when compared to generic drugs. However, with many leading biologics losing their patent protection by 2020; the market entry and opportunity for biosimilars is set to expand

Asia Pacific alone develops more biosimilar products than anywhere else in the world and regulatory bodies are putting more resources to handle biosimilars applications and more biopharma companies to develop biosimilars products. This event will discuss commercial strategies, insights on how regulatory & approval process work in region, opportunities for market expansion and highlights on R&D. Join us to explore the current global climate for biosimilars, evaluate competition and benchmark with industry peers on how to navigate the changing regulations and landscape of the biosimilars market and effectively bring these programs to market.

KEY THEMES DISCUSSED:-

  • Discussing country-specific & strategies on market access of biosimilars 
  • Role of patient groups and importance of patient-centric approaches – solving and shaping your access strategy
  • Exploring ways to break into India’s private market
  • What are the current demands on vaccines in India?
  • What is the future consideration for biosimilar and how is the biosimilar market formulating globally?
  • What are the terms of regulations and IP stands before biosimilars?
  • Biosimilar and Biobetters development
  • Manufacturing biologics: How to prevent human errors using automation
  • Biosimilars in India: What’s next? Consideration for long term market sustainability and market access strategies, opportunities and commercial challenges
  • Technology transfer strategies for market access
  • Licensing, partnerships and strategic alliance management
  • What should you be looking for in your partners and how can you make your business more attractive to them?
  • Safety & Risk Management System for Biosimilars
  • Regulatory framework for risk management
  • Biosimilar regulations and development updates
  • Strategies for improving regulatory expertise and cross-nation support for promoting regulatory policy innovation
  • Be part of a major networking opportunity

WHO SHOULD ATTEND:-

CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, and Senior Scientists from the following roles:

  • Biopharmaceuticals/ Biotherapeutics
  • Follow on Biologics/Follow on Proteins
  • Biologics/Biotechnology/ Biogenerics
  • Legal Affairs
  • Intellectual Property
  • Health Economics
  • Pricing and Reimbursement
  • Clinical Immunology
  • Principal Scientist
  • Chief Scientific Officer
  • Process Control and Analytical Technologies
  • Analytical Characterisation
  • Regulatory Compliance
  • Pharmacovigilance
  • Drug Safety & Risk Management
  • Quality Affairs/ Quality Control
  • New Product Development
  • Process Science
  • Portfolio Management
  • Research & Development
  • Business Development
  • Business Operations
  • Scientific Affairs
  • Commercial Affairs

WHY SHOULD YOU ATTEND?

 
Get more from the event, with a broader scope bringing the whole communications value chain together? Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. Whether you are on the branded or generic side, you cannot afford to miss this opportunity to benchmark your tactics and strategies against the industry leaders who will be the first to traverse the pathway. Devise an immediate action plan for your biosimilar prosecution and litigation strategies in light of the barriers to entry, research and development costs, and regulatory hurdles, which are balanced against an enormous potential for increased profit margin

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:30 – Chairperson opening remarks

MARKET OVERVIEW & ANALYSIS


09:40 – Topic TBC

LALIT LAKHWANI, Associate Director and Head of Clinical strategy,
Dr. Reddy's Laboratories


10:10 – Exploring ways to break into India’s private market

  • How to point the fragmented reimbursement system and the price ceiling in India?
  • What are the current demands on vaccines in India?
  • How should companies price their drugs to be competitive in this market?
  • What are the new accesses for consumer product? And how industries can expand their presence and sales in India?


10:40 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES


11:00 – DISCUSSION WITH EXPERTS: What is the future consideration for biosimilar and how is the biosimilar market formulating globally?

  • What is the recent approval for biosimilars sale in major market and how they made it?
  • What are the terms of regulations and IP stands before biosimilars?
  • How can India better establish itself in the global market?
  • Future biosimilars trends: present global market condition and exposures
  • India’s latest biosimilars guidelines: Opportunities and threats to generics and innovation driven pharma
  • Biosimilar development in clinical trials
  • Focusing on the lifecycle development of control strategies for biosimilar products
  • Comparability versus similarity: physician and patient perspectives on biosimilar uptake and when patients should be switched
  • Salient differences between Indian guidelines and WHO or international Guidelines on Biosimilars

Moderator:

Panellists:

ROSHAN PAWAR, Senior Medical Advisor, Oncology, Alkem Laboratories
RAVISHANKAR KASTURI, Vice President - Development & Manufacturing, Reliance Life Sciences

ANIL KUKREJA, Medical Director, Roche Pharmaceuticals

ANITA KRISHNAN, Assistant Director, Head Bioanalytical Team, Lupin
HEMANT DHAMNE, Senior Research Scientist, Intas Pharmaceuticals (Biopharma Division)
AMMAR RAZA, Medical Director, Allergan


11:50 – Biosimilar and Biobetters development

  • Biosimilar and biobetters development and clinical case studies
  • Designing and conducting global clinical trials
  • Designing clinical frameworks and using data to effectively showcase bio-similarity
  • Opportunities in biobetters development
  • The latest on demonstrating interchangeability
  • Approaches to harmonizing immunogenicity testing


12:20 – Manufacturing biologics: How to prevent human errors using automation

  • Identifying prevalent human errors in manufacturing processes
  • Exploring possible automation solutions to eradicate
  • Analysis on productivity improvements
  • How does increased automation change the role of humans?


12:50 – Networking luncheon

Afternoon Chair person


PRASHANT BODHE, Director, CliniSearch


14:10 – DISCUSSION WITH EXPERTS: Biosimilars in India: What’s next? Consideration for long term market sustainability and market access strategies, opportunities and commercial challenges

  • Key developments in India’s market landscape in terms of investment volume, regulations, competition and initiated projects
  • India is a highly rivalrous biosimilar market: How to address challenges in staying relevant and ahead of competition
  • Distinguish suggestions to meet the possibilities and demands at the post marketing phase of a biosimilar
  • Analyse the possibility of looking into commercialisation of biosimilars abroad, improvement of bio-betters and advanced drugs; as well as what organizations, can anticipate while planning to venture into biosimilar development
  • Ways to ensure long-run sustainability of the biosimilar manufacturer as a whole
  • Streamlining approval and access for follow-on biologics
  • Opportunities and challenges in bringing future biosimilars to market
  • Case studies for biosimilars product from current market analysis
  • Clinical strategies for biosimilars
  • Development of processes for biosimilars, particularly with the aim to achieve molecular similarity as needed by regulations in order to ensure clinical relevance

Moderator:
PRASHANT BODHE, Director, CliniSearch


Panellists:
SHUBHADEEP SINHA, Vice-President & Head (Global)- Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Labs

KIRAN KALAVADIA, Vice President,
Cipla
SAMIR KULKARNI, Independent Biosimilars Professional Expert
ARUN BHATT, Consultant – Clinical Research & Development


14:50 – Biocon Academy - addressing skill challenges in Biopharma

Biotechnology is a relatively young field in India, and it can sometimes be challenging to source for helpful manpower as real talented young individuals often get allured by overseas opportunities. This case study will share Biocon’s success story in building an academy with financial support and assistance to help young graduates to explore more options in their career, whilst growing essential talents to support the local ecosystem in India.

BINDU AJIT, Program Director,
Biocon Academy

15:20 – Afternoon Tea/Coffee


15:40 – Regulatory landscape for clinical development of biosimilars - focus on ROW

SHUBHADEEP SINHA, Vice-President & Head (Global)- Clinical Development, Medical Affairs & Pharmacovigilance, Hetero Labs

REGULATORY


16:10 – DISCUSSION WITH EXPERTS: Biosimilar regulations and development updates

  • Reducing gap between regulatory science and medical practice: Platforms & tools – that could inspire others to follow
  • Regulatory science and medical practice: how to cut down the gaps
  • Connecting the dots? Towards international regulatory convergence
  • What are the key new international developments? What can we adapt from those?
  • Strategies for improving regulatory expertise and cross-nation support for promoting regulatory policy innovation
  • Examine current thinking from industry and regulators on requirements for post approval changes to biosimilar products
  • Global harmonization in quality and regulatory requirements - are we on track?
  • Current regulatory roadblocks for expedition of biosimilars and current standards for biosimilarity

Moderator:
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates

Panellists:
HANMANT BARKATE, Vice President & Head Medical Services (India & MEA), Glenmark Pharmaceuticals
ALAP GANDHI, Head, Medical Affairs, GSK

MILIND NARVEKAR, Senior Director Generic Regulatory Affairs, Teva Pharmaceuticals

SONIKA SHAH, Regulatory Affairs Head, Amgen

VIJAY NAG THOTA, Head-Quality & Regulatory, SciGen BioPharma
MAYUR PARMAR, Drugs Inspector, FDA
MANALI AGRAWAL, Head Regulatory Affairs, Bayer


16:50 – Chairperson’s closing remarks and end of conference


17:00 – 18:00 – Networking Drinks Session

MAYUR PARMAR

Drugs Inspector

FDA

Mr. Mayur Parmar is working as Drugs Inspector in Food and Drugs Control Administration, Ministry of health and family welfare, Govt. Of Gujarat. He is carrying five years of rich experience and during his tenure he has inspected various Drug manufacturing sites, drugs Distribution sites, hospitals, blood banks and blood storage centres as per Indian as well as WHO guidelines. With five years of experience of Drug Regulation, Mayur has investigated more than 125 NSQ drugs and launched Prosecution for spurious and misbranded drugs. Prior to it Mayur has completed his M.Pharm with specialization in New Drug Delivery System from Maharaja Sayajirao university of Baroda, Gujarat with two gold medals for securing first rank in the university. He was honoured for Excellence in Academic Carrier at BIPAAS Alumni. He has published four research papers in International and National journals. His views on Pharma regulations have been published in various magazines like eHealth and others. He is pursuing his Ph.D in New Drug Delivery System.

He is a Member of WHO team for up gradation of National Regulatory system. He has chaired two international conferences and speaked at various national and international forums.

He is having industrial experience in formulation development and Intellectual property management. Apart from it, He is actively involved in the various social activities for welfare of underprivileged through “REASON FOR SMILE” organization.

A Huge believer of lifetime learning - Mayur constantly strives to improve himself, both on personal and professional front.

BINDU AJIT

Program Director

Biocon Academy

Bindu Ajit is the Program Director and Head of Biocon Academy and is   responsible for the overall operations and management of Biocon  Academy.

She manages all partners, faculty and  internal stakeholders for the effecient administartion of BA as the Centre of Excellence for Advanced Learning in Applied BioSciences.   She works closely with the Leadership Team and Subject Matter Experts at Biocon  Partner Organizations and Universities to bring the best education and learning experience for students at the Academy.

Bindu has a rich experience of over 20 years and a successful track record across Learning and  Development, Training and People Management roles in various leading Organziations like ANZ, Oracle, Convergys, NIIT etc.

Prior to joining Biocon Academy she was at ANZ, where she headed ‘India Learning Services’ vertical and also led the Global Learning Delivery team.  As the Business Learning Manager  for India and Asia, she worked with various business units to support them in their business goals and priorities by building enabling teams through learning, coaching, and and development.

She is a Post Graduate in Analytical Chemistry from Madras University and has a Bachelor’s Degree in Education.

MILIND NARVEKAR

Senior Director Generic Regulatory Affairs

Teva Pharmaceuticals

LALIT LAKHWANI

Associate Director and Head of Clinical strategy

Dr. Reddy's Laboratories

RAVISHANKAR KASTURI

Vice President - Development & Manufacturing

Reliance Life Sciences

HANMANT BARKATE

Vice President & Head Medical Services (India & MEA)

Glenmark Pharmaceuticals

ARUN BHATT

Consultant - Clinical Research & Development

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.

Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.
Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.

In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.

Dr Bhatt is the recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.

Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.

Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials.

Dr Bhatt has more than 100 publications in national and international journals.  He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”.

SAMIR KULKARNI

Independent Biosimilars Professional Expert

SHUBHADEEP SINHA

Vice-President & Head (Global)- Clinical Development, Medical Affairs & Pharmacovigilance

Hetero Labs

MANALI AGRAWAL

Head Regulatory Affairs

Bayer

KIRAN KALAVADIA

Vice President

Cipla

AMMAR RAZA

Medical Director

Allergan

Physician specialized in Clinical Diabetology and an alumnus of Indian Institute of Management Bangalore (IIMB), with over 19 years in Healthcare in diverse settings – Pharma majors (MNCs and Indian multinational companies), Pharma R & D, and Clinical practice settings (both Hospital- and office-based clinical diabetology practice).  Worked across biopharma in medical affairs, clinical development, medical governance, MSL management, medical information, Phase 4 studies and pharmacovigilance– innovative small molecules, biologics, vaccines, biosimilars and branded generics.

ANIL KUKREJA

Medical Director

Roche Pharmaceuticals

ANITA KRISHNAN

Assistant Director, Head Bioanalytical Team

Lupin

SONIKA SHAH

Regulatory Affairs Head

Amgen

Sonika Shah is heading Regulatory Affairs function in Amgen India. Prior to joining Amgen, Sonika worked for various organizations including Sanofi, Bristol-Myers Squibb, UCB & Bayer is & has a robust experience of more than 13 years managing regulatory affairs for biological and new chemical entity and drug safety.

She has vast experience in developing and executing regulatory strategies for new drugs (biologicals and NCE), clinical development and life cycle management. In previous roles she has handled regulatory activities for Srilanka, Bangladesh, Nepal in addition to India. She played an instrumental role in setting up safety function in her past organization. She has the experience of working with different regulatory agencies like DCGI, DGFT, State FDA and CDL/CDTL.

She is active member of Industry associations like OPPI (Organization of Pharmaceutical Producers of India)-Medical and Regulatory Working Group and regulatory council of ISCR (Indian Society for Clinical Research).

MILIND ANTANI

Partner In-Charge - Pharma LifeSciences

Nishith Desai Associates

Dr. Milind Antani is a Partner in charge of the Pharma & Healthcare Practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC, Munich and New York. He is also partner in-charge of Social Sector practice and Nanotechnology practice.

Dr. Antani represents clients on strategy matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, collaborations including joint ventures and formation of new companies. He also advises clients in e-Health and tele-medicine on business strategy from legal and regulatory perspective.

He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS, and Pharma and Life science. The have also contributed a chapter on India in ‘Commercialization of Healthcare-2nd Edition Global Guide’ published by Thompson Reuters in 2015. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.

He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014 and 2015 in the ‘Regulatory’ section as only lawyer from India.

Dr. Antani practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates as a lawyer.

He has also successfully attended "Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.

HEMANT DHAMNE

Senior Research Scientist

Intas Pharmaceuticals (Biopharma Division)

VIJAY NAG THOTA

Head-Quality & Regulatory

SciGen BioPharma

ALAP GANDHI

Head, Medical Affairs

Glaxo Smith Kline (GSK)

ROSHAN PAWAR

Senior Medical Advisor, Oncology

Alkem Laboratories

PRASHANT BODHE

Director

CliniSearch

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LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.

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Kohinoor Continental Hotel

Address: Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
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Testimonials from our past Biosimilars Congregations

 

 

Well discussed topics with a distinguished and prolific panel of experts in their respective fields in Biosimilars - Senior Business Analyst, Jakob & Partners

The only way to stay up to speed in this fast evolving market is to touch base with your peers. The biosimilars congregation is the right place to do it - Global Brand Manager & Global Biosimilars Business Intelligence, Merck Serono

I think the event was great and really threw insight on positioning biosimilars vis a vis other drugs on the regulatory side in India and World and what are challenges faced by industry as well as government and also regulators It was a great learning - AVP & Head Lega, Wockhardt

Excellent workshop. It did meet our expectation in term of complete representation of the biosimilar development - Senior Manager, Regulatory Affairs Sanofi

It was a splendid show yesterday, and esp with you and Sid managing the whole show so smoothly, was very well seen. Virtue Insight Staff were very helpful all throughout - Director, VIaTAL Pharma Consulting

All the topics picked up very good and were pretty informative. The panel discussions brought very nice views and insights on agenda points - BUSINESS DEVELOPMENT & PM, LUPIN BIOTECH

New topic to organize by virtue insight appreciate your choice of current hot topics participated as a deligate with inquisitiveness to learn more biosimilars mission accomplished - HEAD PV, BMS INDIA

Well done, most of the speakers selected for the conference were excellent and there was informative as well as participative discussion - MANAGER - BD & PROGRAM MANAGEMENT, LUPIN

A good interactive & learning session delivered by expert panels - BUSINESS ANALYST, JAKOB & PARTNERS INDIA PVT LTD

The conference is good to know about the regulatory scenario - Senior Research Scientist, Quantimmune Solutions

Good Discussion about commercial Challenges and lessons with 1st class biosimilar products and challenges/ development, regulatory and commercial with biosimilars MABs - Medical Assessor in Licensing of Biological Products, MHRA

Keeping in mind actuality of the biotech drug discovery and development, the Biosimilars Congregation 2012 defined  topics can be for congratulations only. Key items as pharma and generics industries approach relative to emerging and developing biosimilar market, clinical trials changes in clinical practice and evolution in understanding of the biology of the disease, challenges in clinical study design for biosimilar development arising from endpoint variability, identifying issues and solutions surrounding biosimilars etc., that have been discussed at the conference, gave the course for  predicting future trends inside the pharmaceutical industry worldwide. Choice of the lecturers as well as panelists  with so divergent, but so complementary  professional background, gave the Meeting special seriousness.Owing to this heterogeneity, the success of the after - lecture discussion as well as the panel ones, was even more productive and promotional  for next similar meetings. Moderators were professional and  prepared for all  the Keynote Addresses. They successfully  managed to bridge the gaps arisen from divergent attitudes occurred during the discussions. It contributed to the air of specificity and  uniqueness of that very Meeting. Summaries done from this Meeting shall remembered and incorporated in my professional work. I do hope that I could be able to participate your next Meeting /2013./ - Violeta Stanimirovic, Expert of medicines and medical devices agency, Serbia - Alims & expert of Montenegrian National Drug Agency - CALIMS Excellent cross section of up to date & future directions of Biosimilars - Director, Voisin Consuting Lifesciences

The programme and the format were very good and the atmosphere provided great encouragement for the networking.  It was timely organised allowing the participants to exchange opinions on very recent regulatory changes in the US and the EU - Scientific & Regulatory Director, Regem Consulting Ltd

All in all, Biosimilars Congregation 2012 was a very worthwhile and informative conference - Global Marketing Manager-Biotechnology, SACHEM

The Biosimilars Congregation proved to be an insightful range of presentations which covered the most important aspects of the biosimilars field. I’d recommend it to all stakeholders, manufacturers and regulators alike, who wants to network and gain more up-to-date knowledge in this exciting business area of biologics - Director, Corporate Business Development, CMC Biologics A/S

The presentations were informative and the panel discussions engaging,  covering key and important topics of debate.  The food and wine reception were excellent and allowed for relaxed networking opportunities - Director, Voisin Consulting Life Sciences

Biosimilar Congregation was a really good conference, well organized and of good quality - Senior Director Biopharmaceuticals and Scientific Advisory, Nuvisan GmbH

Biosimilars Congregation 2012 organised by Virtue Insight was a professionally managed event that was able to pull together a broad and relevant agenda presented by a well informed and insightful faculty. It was also very timely with the recent release of the US Biosimilar guidance which added a lot of new information that has not been previously discussed. I would certainly be interested in attending future events organized by Virtue Insight - Biosimilars and Proprietary Marketing Director, EMEA, Hospira, UK

The Biosimilars Congregation  has been a very informative gathering especially with respect to the future landscape and opportunities in Biosimilars - Managing Director - UK, Wockhardt

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