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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”

Euro Biosimilars 2018 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 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

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 2-3 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
The U.S. takes the lion's share (49 percent) of the global biologics market value and generates half of the sales value growth as well. The EU accounts for 22 percent of the market's sales value and 14 percent of its value growth. In contrast, emerging markets represent just a sliver of the sales pie, with 7.5 percent share. Thus, biologics market growth is still largely driven by mature markets. The global biologics market had reached $170 billion in sales value in 2012, accounting for 18 percent of the overall market. The five top 10 global products in terms of sales volume are biologics, wherein 2008 it was just two.
The market in the APAC region for biosimilars reached $605 million in 2010 and $683 million in 2011. The market is expected to reach $1.1 billion by 2016, a CAGR of 10.3%. The market in the United States for biosimilars reached $507 million in 2010 and $1.1 billion in 2011. The market is expected to reach $1.3 billion by 2016, a CAGR of 4.1%.
  • Track 5-1Biosimilars China and Asia Pacific
  • Track 5-2Biosimilars India
  • Track 5-3Biosimilars USA
  • Track 5-4Biosimilars Europe

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 6-1Next generation biosimilars
  • Track 6-2Future of biosimilars
  • Track 6-3 Application of biotechnology in pharmaceutical product development

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 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
The safeguarding of product trade secret, its formulations and other process parameters by law is usually covered by IPR. It includes those as patents, copyrights, industrial design rights, trademarks etc. IPR is of prime importance in the field of biologics and biosimilars. Most scientist and industries tend to retain their monopoly business by exercising the IPR.
The very name Biosimilars calls for the occurrence of Intellectual Property rights laws and by-laws. Hence this session is of utmost interest to the attorneys and law personnel.Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law. Eight years of exclusivity would keep biologic medicines out of the hands of many who need them. Prices frequently exceed $100,000.
 
  • 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

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 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
Bioequivalence focuses on the equivalence of release of the active pharmaceutical ingredient from the pharmaceutical product and its subsequent absorption into the systemic circulation. This session has utmost importance in context to the fact that only a suitably bioequivalent drug candidate that conforms the results in all respects to the original licensed product can be called as biosimilar drug.
Of all attempts towards developing a follow on biologics or a biosimilar drug the main detection point stands at the bioequivalence assessment. Once the bioequivalence has been obtained it can be 70% ascertained the dtug qualifies to be a suitable biologics or biosimilars.
 
  • 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 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 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
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 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.

By 2002, the FDA had approved 36 new biologics, followed by 37 more in 2003, another 40 in 2004 and 39 more in 2005. By 2006, the leading category of biologic treatment, the red blood cell enhancer recombinant erythropoietin (EPO), generated $14 billion in sales revenues, or 40 percent more than the best-selling traditional pharmaceutical, Lipitor. More than 300 therapeutic antibodies currently are in clinical development and trials, compared to just 13 that already are widely available due to legal issues.

  • 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

Biologic Drugs, or biologic response modifiers, are medications genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. Biologics target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. Biologic response modifiers (biologics for short) are drugs that are genetically engineered from a living organism, such as a virus, gene or protein, to simulate the body’s natural response to infection and disease. They target proteins, cells and pathways responsible for the symptoms and damage of rheumatoid arthritis and other types of inflammatory arthritis. The proteins targeted include tumor necrosis factor (TNF), interleukin-1 (IL-1) and interleukin-6 (IL-6), which are involved in joint inflammation. Biologics are typically reserved for people whose arthritis has not responded well to disease-modifying antirheumatic drugs (DMARDs).

  • Track 17-1Biological drugs
  • Track 17-2Advances in biological products
  • Track 17-3Generic biological drugs

Biological Medicine works with the biology of the body and its natural healing capabilities as well as the spiritual, emotional and physical aspects of disease. Dis-ease means that the body’s regulation is not working properly and needs to be brought back into its natural dynamic state where the immune system is in full regulation.  It therefore looks for root causes for the presenting symptoms of disease- the underlying factors causing a person to present with a certain illness.  These root causes may consist of several factors which have built up over time and can include; diet, food allergies, intestinal disturbances, family history, stress, environmental factors, heavy metals, dental problems, hyperacidity, trauma, exposure to bacteria or viruses or electromagnetic disturbances.

A Biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for product approval). Instead of conducting expensive and time consuming in vivo studies, a dissolution test could be adopted as the surrogate basis for the decision as to whether the two pharmaceutical products are equivalent. At that time the Biowaiver was only considered for scale-up and post approval changes (SUPAC) to pharmaceutical products.

The term biobetter refers to a recombinant protein drug that is in the same class as an existing biopharmaceutical but is not identical; it is improved over the original. Biobetters build on the success of existing, approved biologics but are considered less of a commercial risk than developing a brand new class of biologic. Biobetters are not entirely new drugs and they aren't generic versions of drugs, either. While many consider biosimilars to be generic versions of biotech drugs, it isn't possible to create a generic biologic drug. That's because biopharmaceuticals are produced in living organisms - such as animals or bacteria - and cannot be copied exactly.

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.