The Future of Biosimilars: Market Need, Issues & Next Steps

Thursday, March 27 2014
8:00 am – 10:00 am

Location: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA

The Patient Protection and Affordable Care Act of 2010 (PPACA) includes the Biologics Price Competition and Innovation Act of 2009, which provides for the U.S. Food and Drug Administration’s development of a pathway for the expedited approval of follow-on biologics — or biosimilars.

Biologics are large-molecule drugs produced in living organisms and are used to treat some of the most serious life-threatening diseases. They are more expensive than chemical drugs — R&D can cost $1.2 billion vs. $500-800 million for chemical drugs. For example, a year’s treatment with adalimumab (Humira) for rheumatoid arthritis or Crohn’s disease is $50,000 and imiglucerase (Cerezyme) for Gaucher disease is $200,000. As cost-effective alternatives to branded biologics, biosimilars offer advantages to both payers and patients.

Unlike generic chemical medicines where active ingredients are identical, biosimilars are unlikely to be identical to the originator biologic. Biosimilars made by different manufacturers differ from the original product and from each other. Although not expected to be direct copies of originator biologics, given the complex structure and processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, safety and efficacy. Minor differences with the active ingredient are permitted so long as they are demonstrated not to be clinically meaningful. The patents of a growing number of biologic medicines have already expired or are due to expire, leading to an increased interest in the development of biosimilars.

Our panel of experts will each address key topics.

Michael S. Wyand DVM, PhD, Senior Vice President Clinical & Regulatory, Epirus Biopharma

“Approaches for Development of Biosimilar Molecules”

Presentation will discuss current issues in achieving biosimilarity of protein therapeutics including analytical, regulatory and clinical approaches.

Indu S. Javeri, Ph.D. CuriRx Inc.

“Role of Stability FingerPrinting™ in mitigating the risk associated with manufacturing of Biosimilars”

This presentation addresses some of the basic key requirements of having process controls that would not only allow for mitigating the risk associated with manufacturing but also allow for product with quality, safety and efficacy similar to the reference product.

John Jaeger, Vice President, Market Access Insights, Decision Resources Group

“Navigating the Mine Field – Commercialization of Biosimilars within the US Market Access and Reimbursement Landscape”

While manufacturers tend to be focused on the clinical role and applicability of biosimilars (justifiably so), also needed is focus on the commercialization process and dynamics within the U.S. reimbursement setting to truly optimize the value of biosimilars to patients, physicians and payers across the entire healthcare value chain.

Moderator:

Shikha P. Barman, Ph.D., CEO & CTO, Integral BioSystems

 

This Forum is presented by the Formulation and Drug Delivery Forum Working Group.

 

Bios:

Shikha P. Barman, Ph.D., CEO & CTO, Integral BioSystems

Dr. Barman has over 20 years of experience in the translation of concepts from the lab into clinical and commercial drug products. Her expertise is in the design of cell-targeted delivery systems, customized to permeate biological barriers such as the skin, ocular and intestinal barriers. Prior to founding Integral BioSystems as a hybrid CRO/innovation-based company with Boston-area patent attorney Dave Karasic, she was Vice President of Pharmaceutical Development and Preclinical Sciences at Follica, Inc. responsible for multiple departments in CMC, Preclinical DMPK and Toxicology, developing dermal products in antimicrobials, onychomycosis, hair growth and acne. Prior to Follica, she was Senior Director of CMC/Pharmaceutical Development at Inotek Pharmaceuticals, Inc. developing products utilizing novel small molecule PARP inhibitors and A-1 agonists into ocular treatments for glaucoma and diabetic retinopathy and an injectable for a fast-acting treatment for atrial fibrillation. She was also Head of Vaccine and Transdermal Development at Sontra Medical Corporation, developing products delivered using an innovative transcutaneous ultrasound device (SonoPrep™). One of these products is marketed as a continuous glucose monitoring device. At Zycos, Inc., Dr. Barman was Head of Gene Delivery, targeting PLG microsphere-based DNA-based therapies for the treatment of HPV and cancer. Lastly, at Focal, Inc., she helped develop one of first lines of biodegradable tissue sealants, now marketed as FocalSeal, by Genzyme BioSurgery.

 

John Jaeger, Vice President, Market Access Insights, Decision Resources Group

John Jaeger is Vice President, Market Access Insights with Decision Resources Group. He has successfully led and completed well over 200 bespoke managed markets consulting and market research initiatives in a variety of payer customer segments within US and ex-US markets over the past 10 years. Mr. Jaeger’s experience within the biopharmaceutical sector includes both pre-launch product commercialization, as well as the development of segment-driven mature brand strategy for products in a wide range of different mechanisms of action and therapeutic categories for both innovator brands and biosimilars. More specifically, Mr. Jaeger has also completed numerous portfolio optimization engagements centered on tracking emerging healthcare trends, specifically associated within the Affordable Care Act, which has helped clients optimize their portfolio based on opportunities and risks that are likely to emerge during the biopharmaceutical commercialization process. In addition to his current role at Decision Resources Group, Mr. Jaeger is currently a marketing professor at the University of Sciences in Philadelphia for their MBA program and has also taught for the Rutgers Executive MBA program. Mr. Jaeger has a BA in Public Administration from Shippensburg University and a Masters of Public Administration in Public Health from the University of Delaware.

 

Indu S. Javeri, Ph.D., CEO, President, CuriRx Inc.

CuriRx provides a board range of Contract Research and Development services for Biotech and Pharmaceutical products including Vaccines, Generics and BioSimilars. She earned her doctorate from University of Oklahoma and has 24 years of experience in Drug Development of Biologics and Pharmaceuticals, at Genetics Institute, Abbott Biotech, and Cambridge Neurosciences. For last 13 years, she was CEO of Formatech and was responsible for developing large number of products including analytical methods/formulations for biologics and small molecules. Dr Javeri has developed intellectual properties based on nanoparticle platform technology for solubilizing insoluble molecules.

 

Michael S. Wyand DVM, PhD, Senior Vice President Clinical & Regulatory, Epirus Biopharma

Dr. Wyand is currently Senior Vice President of Clinical and Regulatory at Epirus Biopharmaceuticals, a Boston based biotech company developing biosimilar protein therapeutics for emerging markets. Prior to Epirus, Dr. Wyand held senior executive positions in companies developing TNF-inhibitors for radicular pain and cancer vaccines for prostate and pancreatic cancer. In 2010 Dr. Wyand was a member of the executive team that closed the acquisition of BioAssets Development Corp. by Cephalon/Teva. Dr Wyand trained in comparative pathology at Harvard Medical School, received his DVM from Purdue and graduated as a University Scholar Phi Beta Kappa from the University of Connecticut.

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