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BioSimilar Drug Development World

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  • 1. Innovations in development for the biosimilar industrywww.healthnetworkcommunications.com/biosimilar hnetworkcommunications.com/biosimilar
  • 2. Contents Carsten Brockmeyer, Owner and Managing Director, Brockmeyer Biopharma GmbH Rajiv Dua, Analytical & Stability Coordinator, Lupin Biotech Prof Heinz Haenel, Diabetes Division R+D Projects, Sanofi Aventis Dr Rustom Mody, Biosimilar Development Lead, Intas Biopharmaceuticals Anita O’Connor, Consultant, Anita O’Connor Consulting Dr Deven Parmar MD, Vice President - Global Clinical Research, Wockhardt Joe Zhou, CEO, Wison/Genor Pharma About Biosimilar Drug Development World Europe 2012All the respondents to our e-book are speaking at Biosimilar Drug Development World Europe 2012.This conference boasts a whole host of industry speakers. In addition to the above speakers further speakers include: Joerg Windisch, Global Head, Technical Development, Sandoz International GmbH Cyrus Karkaria, President, Biotech Division, Lupin Ltd Brian Hosung Min, Vice President, Strategic Business Development, Samsung The Honorable Henry A. Waxman, Member of Congress, USA Alexandre Moreau, Clinical Assessor in Oncology, Afssaps Dr Marie-Christine Bielsky, Senior Medical Assessor, Biologicals and Biotechnology Unit, Licensing Division, MHRA Dr Phul Parvinder, Pre-clinical Assessor, MHRA This conference will ensure your biosimilar strategy is effective and commercially sound. For full details visit www.healthnetworkcommunications.com/biosimilar
  • 3. What do you think is the number one hurdle forCarsten biosimilar development today?Brockmeyer The development of a biosimilar requires a target directed approachOwner and Managing to achieve a molecule that is similar to an existing biological medicine.Director However, since we are dealing with living cells to produce these biologics, and since we have this batch-to-batch variability, it is notBrockmeyer Biopharma expected that the two molecules are identical, minor differences areGmbH acceptable - if they are sufficiently justified. If similarity has been demonstrated on a physico-chemical, bio-physical and biological level,Presentation: Workshop then the number of scientific and operational issues in clinicalleader- Successful development, registration and commercialization can be overcome.registration of biosimilarsand biobetters in the EU What skill set does the industry need to use for the safe and quality development of biosimilars? Excellence in analytics, target directed approaches in product development, out-of-the box thinking in clinical development and registration, state-of-the-art quality systems and standards in development and manufacturing, scale-up and commercialization expertise, and last but not least good project management skills. What challenges are unique to clinical trials for biosimilars and how can we overcome these? Clinical development of a biosimilar is a confirmation of a target directed CMC development and requires a lot out-of-the box thinking. Bioequivalence to the reference product has to be shown first, followed by demonstration of similar efficacy and safety in a sensitive indication, which is again done in a direct comparison with the reference product. In many cases it will need an equivalence study design. Dose finding studies are not necessary and extrapolation to other indications, which are approved for the reference product, should be possible based on the same mechanism-of-action. Immunogenicity is an important aspect and needs specific observation. On the operational side most of these studies will be multinational studies including a larger number of developed countries and less developed countries. There are logistic challenges with supply, cool chain, site and patient recruitment, GCP, etc. How to overcome these challenges? Build the right talent in-house and choose the best organization to work with.
  • 4. Rajiv Dua What do you think is the number one hurdle forAnalytical & Stability biosimilar development today? I think for Biosimilar development today, the major hurdle is lessCoordinator clarity and complexity in terms of intellectual property and lack of marketing strategies besides huge cost involved in complicatedLupin Biotech manufacturing, establishing physicochemical and Clinical comparability to get the biosimilar products comparable toPresentation: Cold chain Reference Medicinal Product (RMP) in terms of quality, Safety and Efficacy.management forbiosimilars What skill set does the industry need to use for the safe and quality development of biosimilars? • Most important is technically and scientifically sound team. • Quality by Design Technology (QbD), Process Analytical Technology (PAT), Design of Experiments (DOE), Regulatory Strategic roadmap, appropriate clinical strategy and trial design are the foremost skill set required for the safe and quality development of Biosimilars. • The implementation of these technologies will contribute towards defining Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Operating Range (OR) for the products, which will further help us to understand process, product, less development costs and to avoid post approval changes. What challenges are unique to clinical trials for biosimilars and how can we overcome these? • Unavailability of innovator Clinical data is the main hurdle for biosimilars clinical development. If it is available biosimilar CT protocol can be designed that reduce CT cost & will generate effective clinical data. This can be overcome with the help of regulatory agencies (FDA, EMEA), who can provide access to the innovator clinical data. • The unique challenges for Biosimilars clinical trials include: Immunogenicity concerns. Extent of characterization of the mechanism of action and targets of the innovator compound. Indication and patient population. The complexity of clinical endpoints that may be acceptable to regulatory authorities globally. • To overcome these challenges, few strategies shall be applied: Extensive characterization of Reference Medicinal Product (RMP) and Biosimilar. Extensive evidence of analytical comparability and non-clinical similarity to RMP must be established in a stepwise process during development. Choosing the countries / Markets where these are an immense need for biosimilar and where regulatory agencies are willing to work collaboratively with biosimilar companies. Selecting an appropriate population and sample size. Incorporating the right clinical endpoints.
  • 5. What do you think is the number one hurdle forProf Heinz Haenel biosimilar development today?Diabetes Division R+D To satisfy the regulatory bodies in their concern of increasedProjects immunogenicity and the lack of methodological expertise of the companies to fully characterise the tertiary structure of theSanofi Aventis peptides besides the other propertiesPresentation: Biosimilars– the devil is in the detail What skill set does the industry need to use for the safe and quality development of biosimilars? Expertise in Phase III immunological trials, analytical expertise to differentiate insulin analogues from regular insulin, ability to check the full by-product spectrum plus possibly the tertiary structure What challenges are unique to clinical trials for biosimilars and how can we overcome these? The identification of immunogenicity is dependent on various factors which are not fully understood. The necessary patient number and exposure time is under debate, depending on the statistical plan and method. On the other hand it is not undisputed in clinical science what impact a modified immunological profile has on the clinical outcome. Example: neutralizing antibodies versus non-neutralizing antibodies.
  • 6. What do you think is the number one hurdle forDr Rustom Mody biosimilar development today?Biosimilar Development Interchange ability not allowed for biosimilars.LeadIntas Biopharmaceuticals What skill set does the industry need to use for the safe andPresentation: Biobetters quality development of biosimilars? Risk-based approach based on analysis of many lots of Reference Medicinal Product to determine limits of Critical Quality Attributes. What challenges are unique to clinical trials for biosimilars and how can we overcome these? Acceptance of Innovator’s product (from Europe) for submission in US and vice-versa.
  • 7. What do you think is the number one hurdle forAnita O’Connor, biosimilar development today?Consultant Money: The costs involved in developing biosimilars for worldwide markets is the number one hurdle in my view. It is extremelyAnita OConnor expensive to manufacture the biosimilar, characterize it alongsideConsulting the innovator molecule, do the required preclinical pharmacology and toxicology studies, and design and execute at least 1-2 clinicalPresentation: Workshop trials.leader- The evolvingquality (chemistry andmanufacturing) paradigmfor biosimilars What skill set does the industry need to use for the safe and quality development of biosimilars? Manufacturing: the success of a biosimilar molecule depends heavily on the manufacturing skills of the developer. The manufacturing (quality) of the biosimilar requires state of the art CMC capabilities and bioanalytical characterization studies as development progresses. If the developer is not experienced in the production of drugs produced by biotechnology from the pilot to the commercialization stage, I think they are at a disadvantage compared to the many CMC plants making these drugs around the world. I see CMC as the foundation of the biosimilar development program because if the molecule is not similar enough to suit the regulatory authorities, it cannot proceed into preclinical or clinical testing. What challenges are unique to clinical trials for biosimilars and how can we overcome these? Clinical trials: right now the designing and executing 1 or 2 clinical trials that meet the approval of multiple regulatory agencies around the world is a bit daunting. The regulatory requirements for biosimilars are far from being similar in the EU, the US and Japan. The challenge is that these regulatory requirements are rapidly evolving; the regulators are in a learning mode because this is truly a nascent area for drugs produced by biotechnology.
  • 8. What do you think is the number one hurdle forDr Deven Parmar biosimilar development today?MD Guidelines in USVice President - Global What skill set does the industry need to use for theClinical Research, safe and quality development of biosimilars?Wockhardt Trained Manpower, scientific AdvisePresentation: Clinical trialrequirements – is the What challenges are unique to clinical trials forextent and depth of trial biosimilars and how can we overcome these?requirements necessary? Assay Development, Protocol Endpoints What do you think is the number one hurdle for Joe Zhou biosimilar development today? CEO Interchange-ability Wison/Genor Pharma What skill set does the industry need to use for the safe and quality development of biosimilars? Presentation: Reference Similarity determination product selection and cell line development What challenges are unique to clinical trials for biosimilars and how can we overcome these? Efficient clinical design with minimal usage of innovative biologic drug(s)
  • 9. Thank you for downloading Health Network Communication’s Biosimilar Drug Development World Europe e-book. All views and opinions expressed in this document belong to the named speaker. For more information please visit www.healthnetworkcommunications.com/biosimilar

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