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11th European Biosimilars Congress, will be organized around the theme “The developmental strategies and uptake of biosimilars through a decade in Europe”
Biosimilars-euro 2018 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Biosimilars-euro 2018
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Biosimilars are the generic version of Biologic drugs. The former is a kindred copy of the reference product with very comparable efficacy, potency and pharmacology with the later. However, the development of a biosimilar product is highly challenging in terms of lead generation, product development, establishing the same pharmacology, formulation and finally gaining the approval from concerned regulatory bodies. Moreover with the rising demand for QbD products and increased patient affordability and accessibility the development of biosimilars in a cost effective becomes yet more challenging.
- Track 1-1Quality by Design for Biologics and Biosimilars
- Track 1-2Biopharmaceuticals development
- Track 1-3 Implimentation of the BPCI Act
- Track 1-4Advertising, promotion and labeling essentials
- Track 1-5Unique considerations for biologics
- Track 1-6Comparability for biologics
- Track 1-7Drug safety essentials
- Track 1-8 Late clinical development essentials
- Track 1-9Early clinical development essentials
- Track 1-10Biologics in genetic disorders
- Track 2-1Biologics in cancer
- Track 2-2Biologics for psoriasis
- Track 2-3 Biosimilar monoclonal antibodies
- Track 2-4 Recombinant therapeutic proteins
- Track 2-5Insulin biosimilars
- Track 2-6Biologics in autoimmune disease
Management of cGMP facility calls for a strict monitoring all factors including analytical strategies, formulation procedures, packaging etc. For biologic products establishing comparability and interchangeability is a big hurdle. For this purpose employment of suitable analytical approach, bioassay, protein analysis, potency testing, safety assurances are highly important. LC/MS analysis for biologic products, characterization of biologics, peptide mapping, Isoelectric Focusing and Capillary Isoelectric Focusing, SDS-PAGE, Thermal Analysis, Particulate Matter Analysis, Thermogravimetric Analysis are some methods commonly used for analysis of biologics and biosimilar products.
On average, facilities outsource 32% of their analytical testing/bioassays (up from 28%) meaning that close to one-third of analytical testing is estimated to be outsourced by the industry.
- Track 3-1Biosimilar multimodal techniques
- Track 3-2Biosimilar bioanalytical methods
- Track 3-3 Bioassay for comparability and potency testing
- Track 3-4Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
- Track 3-5 Biosimilar GMP protein analysis
- Track 3-6Biosimilar electrophoresis
Competitions and/or success in the present pharma industry is determined by the winning patent strategy which mostly pertain to the generic market entry. Generic and branded drug manufacturers both the patent strategy proximally belongs to the Hatch-Waxman Act statutory scheme and ANDA litigations. The Hatch-Waxman Act enacted in 1984 with amendment in 2003 facilitated the entry of generics at an early stage-thereby finishing the battle of branded generic ANDA of blockbuster drugs. All the same the Biologics Price Competition and Innovation (BPCI) Act has maximized the branded-generic patent duel in the biologics realm by imposing a litigated framework on follow-on-biologics. On September 16, 2011 President Obama signed the American Invents Act(AIA) of 2011 indicating a further strategy evolution of patenting branded and generics.
An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6% with one generic competitor, but jumps to 48% with two generic competitors, 56% with three, 61% with four and 67% with five generic producers in a market. Within 2 years of the expiration of the patent of the popular drug Zantac in 1997, generics of Zantac accounted 90% of the treatment’s total sales, and the price for patients was about 10% of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners successfully received EMEA approval for the first European biogenerics, two products containing human growth hormone.
- Track 4-1Licensing of biosimilars
- Track 4-2 BLA filing for biosimilars
- Track 4-3Regulatory prospects of BRIC countries
- Track 4-4Biowaiver approval for biosimilars
- Track 5-1Biosimilars China and Asia Pacific
- Track 5-2Biosimilars India
- Track 5-3Biosimilars USA
- Track 5-4Biosimilars Europe
- Track 6-1Next generation biosimilars
- Track 6-2Future of biosimilars
- Track 6-3 Application of biotechnology in pharmaceutical product development
- Track 7-1Biosimilars Clinical Trials
- Track 7-2Clinical PK/PD studies
- Track 7-3Toxicological studies
- Track 7-4Risk management, and quality affairs
- Track 7-5Targeted cell line development
- Track 7-6Case studies and clinical models
- Track 7-7Biologics Product Life Cycle and Sustainable Market Returns
With Europe that paved way to the uptake of biosimilars over a decade ago, the consequences of Brexit would be potentially harder on UK. Presently UK is no more bound to follow the guidelines of EMA. Also research grants from Innovative Medicines Initiative and Horizon 2020 would no more be available to UK. All the same, EMA has its headquarters in London, UK. The thus arising complications would definitely have certain consequences on the Biosimilars scenario in UK and EU.
- Track 8-1Brexit- Pros and Cons to European pharma market
- Track 8-2Post Brexit changes in Biosimilars regulation in UK
- Track 8-3Fate of biosimilars clinical trials in UK
- Track 8-4Research funding from European organizations to UK based research laboratories
- Track 9-1Pharma Patent Scenario
- Track 9-2Criteria for Patentability and Patent Claims
- Track 9-3Critical research issues
- Track 9-4Patentable subject matter
- Track 9-5Recent Patent disputes and litigations
- Track 9-6Evaluation of highly variable drugs and drug products
- Track 10-1Global impact of biosimilars over generics
- Track 10-2Biosimilars in global market
- Track 10-3Cost and risk management
- Track 10-4Adopting innovative mechanisms such as risk-sharing arrangement
- Track 10-5Global P&R models for the biosimilars and generics market
- Track 11-1Strategies for the bioequivalence assessment of topical dosage forms
- Track 11-2Bioequivalence assessment of respiratory dosage forms
- Track 11-3Bioequivalence approaches for transdermal dosage forms
Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved "innovative" versions of original products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session also finds place for all the biosimilar exhibitiors associated with the field of biosimilar and biologics.
Biosimilar iinovative products are on the rise. The number of new drugs seeking approvals are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of biomilars are expected to be in the market in 2016 compared to in the last 5 years.
- Track 12-11Biotechnology medicinal products for different drugs
- Track 12-2Future of next generation biosimilars
- Track 12-3Biopharmaceuticals development
The objective of this work was to suggest the biowaivers potential of biopharmaceutical classification system which are known to increase the solubility, dissolution, oral absorption of water insoluble drugs. Biopharmaceutics Classification System and invitro and invivo classification discusses about ADME pathways of different drugs. This also includes BCS biowaivers, In vitro diffusion cells for dissolution testing in formulation development, In vitro preclinical ADME/BCS testing.
Until in vitro in vivo correlation achieves the required degree, the biosimilar drug will not be able to meet the needs of the original drug candidate. Hence the proportion of BCS and IVIVC based biowaivers are fairly low ~0.5-1% of total pharmaceutical products.
- Track 13-1BCS biowaivers
- Track 13-2Preclinical and clinical testing for oral drug delivery
- Track 13-3Waiver for In vivo bioavailability or bioequivalence
- Track 13-4Consideration of biowaiver extensions for BCS class III drugs
- Track 13-5In vitro diffusion cells for dissolution testing in formulation development
- Track 13-6Dissolution testing in drug formulation
- Track 13-7In vitro preclinical ADME/BCS testing
- Track 13-8In vitro drug product research
The global biosimilars market is growing at an exponential rate. The CAGR from 2015 to 2020 is projected at over 22%. The biosimilars market is expected to be around $6.2 billion by 2020 from only $2.3 billion in 2015. By the end of this decade the biosimilars would surely occupy 27% of the total pharmaceutical market. Moreover, with the global rise in concern for more accessible-improved- cost effective healthcare, biosimilar drugs would be a more apt choice to the payers, end users, manufacturers over the costly reference biologics. Originator biologics are as costly as about $100,000 per year per patient. Biosimilars on the contrary can be offered at a 30-40% lower price than that of the reference product. However, with all the success stories and opportunities there also lies a sobering 50% failure rate in developing and obtaining license towards marketing of biosimilars. The biosimilars market is categorized into mainly four zones – North America(USA and Canada); Europe(UK, Germany, Spain, Italy, France and Rest of Europe); Aisa-Pacific( China, India, Japan, South Korea) and rest of the world ( LATAM and MENA). Key players of the biosimilars market include Amgen, Hospira, Teva, Sandoz International GmbH, Dr. Reddy’s Laboratory, Biocon, Roche, Celltrion, Catalent, Mylan and Merck. There are also certain other companies which are gaining importance in biosimilar development like LeanBio Pro-Spain, PPD-USA, SGS Life Sciences-UK, Therapeutic Proteins International-USA. The biosimilars development is mainly concentrated in the therapeutic domains of oncology, blood disorders, autoimmune disorders, endocrine disorders and infectious diseases.
- Track 14-1Biosimilars Pharmacoeconomic Modelling
- Track 14-2Return on Investment(ROI) for Biosimilars
- Track 14-3CAGR of biologics and biosimilars in Europe
- Track 14-4Penetration and uptake of biosimilars in different disease sectors
- Track 15-1Current problems in biosimilar pharmacovigilance
- Track 15-2 Adverse drug reactions with biologics and biosimilar products
- Track 15-3Detection and evaluation of drug safety signals
- Track 15-4Role of pharma industries in the improvement of pharmacovigilance system
- Track 15-5Good pharmacovigilance practice and pharmacoepidemiology
The legal issues pertaining to the the follow-on-biologics and biosimilars are one of the most aspects that requires an open discussion. Before the actual advent of biosimilars to the market legal issues have risen in numbers in their developmental stages. Renowned organizations have filed cases against each other two claim their rights and for other legal allegations related to the products. This track is dedicated to discussion of all such cases which has been argued in the court of law.
- Track 16-1Implimentation of the BPCI Act
- Track 16-2Patent protection and infringement issues
- Track 16-3Patent negotiation and litigation phase
- Track 16-4Market exclusivities