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7th European Biosimilars Congress, will be organized around the theme “The developmental strategies and uptake of biosimilars through a decade in Europe”

Euro Biosimilars 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Euro Biosimilars 2017

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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 1-2Early clinical development essentials
  • Track 1-3Late clinical development essentials
  • Track 1-4Drug safety essentials
  • Track 1-5Comparability for biologics
  • Track 1-6Unique considerations for biologics
  • Track 1-7Advertising, promotion and labeling essentials
  • Track 1-8Implimentation of the BPCI Act
  • Track 1-9Biopharmaceuticals development

Biosimilars Market is experiencing a growth at an exponential rate. Presently around 700 biologics are making progress in the research pipelines of nearly 250 biopharma companies. Biosimilar insulins have already started revolutionizing the future drug development in the realm of diabetology. Biosimilars of Adalimumab, Etanercept, Rituximab, Peg-Filgrastim, Trastuzumab are expected to hit the market soon. Biosimilar of Humatrope, biosimilar of Eprex, biosimilar of Neupogen, biosimilar of Remicade have already been enjoying a greater market share in Europe than the reference product itself.. 

The proportion of different biosimilars that reached market are Low Molecular Weight Heparins 44%, Epoetins 19%, HGH 11%, G-CSFs 7%, Interferons 6%, Insulins 5%, Others 8%.

  • Track 2-1Biologics in cancer
  • Track 2-2Biologics for psoriasis
  • Track 2-3Biologics in genetic disorders
  • Track 2-4Biosimilar monoclonal antibodies
  • Track 2-5Recombinant therapeutic proteins
  • Track 2-6 Insulin biosimilars
  • Track 2-7Biologics 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 3-3Bioassay for comparability and potency testing
  • Track 3-4Biosimilar LC/MS analysis for discovery, preclinical, and clinical programs
  • Track 3-5Biosimilar 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 4-2BLA filing for biosimilars
  • Track 4-3Regulatory prospects of BRIC countries
  • Track 4-4Biowaiver approval for biosimilars
  • Track 4-5Patent protection and infringement issues
  • Track 4-6Market exclusivities
  • Track 4-7Patent negotiation and litigation phase

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.

2014 was a banner year for orphan drugs, which are drugs that treat "rare" diseases/disorders affecting fewer than 200,000 people in the U.S. A total of 41 new molecular entities (NMEs) and biologics (BLAs) were approved by the FDA in 2014 - 15 of those were approved in December alone (11 in final two weeks.)

  • Track 5-1Next generation biosimilars
  • Track 5-2Future of biosimilars
  • Track 5-3Application of biotechnology in pharmaceutical product development

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 6-1Brexit- Pros and Cons to European pharma market
  • Track 6-2Post Brexit changes in Biosimilars regulation in UK
  • Track 6-3Fate of biosimilars clinical trials in UK
  • Track 6-4Research funding from European organizations to UK based research laboratories

This track discuses about the generic drugs impact on global biosimilar market , Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars.

A growing global market for biosimilars is gaining momentum in response to the expiration of patents for a number of key biologics and consumer demand to reduce treatment costs. Thus, according to Research and Markets, the global biosimilar market, valued at $2 billion in 2012 is projected to reach $19.4 billion by 2018.

  • Track 7-1Global impact of biosimilars over generics
  • Track 7-2Biosimilars in global market
  • Track 7-3Cost and risk management
  • Track 7-4Adopting innovative mechanisms such as risk-sharing arrangement
  • Track 7-5Global P&R models for the biosimilars and generics market

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx PK/PD studies, Toxicological studies and Aspects of genotoxicity tests.Clinical trials are designed in stages I-IV so as to receive a clear picture of the drug candidate in respect to its pharmacokinetics and pharmacodynamics parameters.

Research estimates that there are 280 Biosimilars in the pipeline, and clinical trials are increasing by 20% per year.Biologics also represent over 40 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

  • Track 8-1Biosimilars Clinical Trials
  • Track 8-2Clinical PK/PD studies
  • Track 8-3Toxicological studies
  • Track 8-4Risk management, and quality affairs
  • Track 8-5Targeted cell line development
  • Track 8-6Case studies and clinical models
  • Track 8-7Biologics Product Life Cycle and Sustainable Market Returns
  • Track 8-8Biologics Product Life Cycle and Sustainable Market Returns

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 de‚Äčvelopment 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 9-1CAGR of biologics and biosimilars in Europe
  • Track 9-2Penetration and uptake of biosimilars in different disease sectors
  • Track 9-3Biosimilars Pharmacoeconomic Modelling
  • Track 9-4Return on Investment(ROI) for Biosimilars

This session of the Biosimilars 2017 will look into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies and ADR related issues.Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.

U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs. In same proportion pharmacovigilance for biosimilars has been comparatively more than other pharmaceutical products.

 

  • Track 10-1Problems in biosimilar pharmacovigilance
  • Track 10-2Adverse drug reactions with biologics and biosimilar products
  • Track 10-3Detection and evaluation of drug safety signals

Entrepreneurs who are willing to put in hard work and invest in the field of biologics and biosimilars will find this meeting the best place to properly shape their drive for the new endeavours. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile.

Biologics are the Future of Medicine and by 2016 it is predicted that eight of the top 10 products on the market will be biologics. The Price of Brand Biologics Continues to Increase  and U.S. average annual spending growth from 2002 to 2007 was 16% for biologics, compared with 3.7% for drugs.The average daily cost of a brand name biologic product is approximately 22 times greater than a traditional drug. Biologics can cost as much as $10,000 to several hundred thousand dollars per year.