The Organizing Committee is pleased to welcome you for the forthcoming International Conference & Exhibition on Biologics and Biosimilars one of its surprising Pharmaceutical gatherings, to be held on March 26-27, 2018 in Orlando, Florida, USA. Biosimilars 2018 focuses on “Market Dynamics of Biosimilars: Perspectives of Payers and Prescribers”. Biosimilars 2018 is a worldwide yearly occasion. This Biologics and Biosimilars 2018 will unite researchers, analysts, business improvement chiefs, CEOs, executives, IP Attorneys, Regulatory Officials and CROs from around the world. Many biologics items are influencing their entrance in the Pharma to showcase and encountering an eminent ascent in their utilization over the ordinary drugs. At Biologics and Biosimilars 2018 meet your intended interest groups from around the globe concentrated on finding out about Biologics and Biosimilars. This gathering would be your single best chance to achieve the biggest array of members from the Biologics and Biosimilars group. The conference will also discuss pharmacovigilance, post-marketing surveillance, and post-approval clinical studies. Compliance with regulatory guidelines is critical to the successful development and commercial launch for Biologics and Biosimilars.
2017 is conceivably a prominent year for enormous take off of biosimilars in U.S., All the same, the EU, is relied upon to have 2017 as its best biosimilar year. Sanford Bernstein's Ronny Gal anticipated that 2017 would be "watershed year for Biosimilars". In the last quarter of 2016 Merck's Remicade encountered lost 26% attributable to rivalry from Celltrion. Gauges say Remsima patents to assume control half of the European market before the finish of 2017. Concerning Amgen's Enbrel, Bernstein experts anticipate that this biosimilar will catch 33% of the market. In US Pfizer propelled Inflectra at a 15% markdown, amid late November. Market experts foresee that Inflectra will record a slower showcase infiltration amid mid-2017 and witness a speeding up proximal to the last quarter of the year. The U.S. additionally confronts pending lawful choices and another presidential organization, which could moderate take-up.
An estimate from Quintiles IMS predicts add up to spending on prescriptions will reach $1.5 trillion by 2021. This will be a 33% expansion from the aggregate spent in 2016. By and large, be that as it may, this development, which will happen at a 4% to 7% CAGR, will be not exactly the 9% development seen in the vicinity of 2014 and 2015. The U.S. specifically will see 6% to 9% development, down from 12 % in 2015. Patent expiries and the passage of biosimilars will assume a key part in the decay of spending. The business, however, is as of now attempting to enable doctors to comprehend the idea of extrapolation. Bringing down the biosimilar cost for the signs just tried in human trials would keep on emphasizing the significance of clinical trials instead of investigation and totality of confirmation. On account of biosimilars versus originator meds, sedate coupons offered by the maker of Enbrel, for instance, really make it more affordable for the patient to buy the originator than the biosimilar, expecting a lower-copay biosimilar level. That is, unless Sandoz, the producer of the endorsed etanercept biosimilar, matches Amgen's couponing program. All things considered, there would be impetus or disincentive for either item, from the patient's point of view.
Both AZ and GSK are showing their expectation to stay in the U.K. Be that as it may, the passing of a pastor, George Freeman, hits at a terrible time for the country. In the U.K., life sciences promotion will be critical to the rising biosimilars showcase. The BGMA and British Biosimilars Association are key bodies to help prompt and lead the charge on Biosimilars in UK post Brexit. Be that as it may, including a supporter of the administration would've unquestionably helped keep the biosimilars mission, and in addition the supportability of the U.K. life sciences, at the front line.
Track 1: Biosimilars
A biosimilar is a biologic medical product which is almost a similar copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" and can be manufactured when the original product's patent expires.
The development of biologics calls for overcoming many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to quality by design (QbD). This Biosimilars conference will look at the facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.
The U.S. takes the lion's share (49 per cent) of the global biologics market value and generates half of the sales value growth as well. The EU accounts for 22 per cent of the market's sales value and 14 per cent of its value growth. In contrast, emerging markets represent just a sliver of the sales pie, with 7.5 per cent 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 per cent 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 4: Biosimilars Analytical Strategies
Analysis of Biosimilars and biologics forms to be one of the most important aspects towards the biologics and biosimilar development process. Biosimilars analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility. This Biosimilars global event also includes Bio analytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.
Track 5: Biosimilars Research Pipeline
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 exhibitors associated with the field of biosimilar and biologics. Biosimilars innovative products are on the rise. The numbers of new drugs seeking approvals are growing at a compounded rate of around 5% half early. Almost 1.5 times the number of Biosimilars is expected to be in the market in 2016 compared to in the last 5 years.
Track 6: Regulatory Approach for Biosimilars
This networking meet will provide an excellent opportunity to the scientists, partners and Pharma leaders from Biopharmaceutical and Biotechnology industries to discuss and learn about the regulatory competencies required for Biosimilars and Biologics. This track includes: Licensing of Biosimilars, Biosimilars regulation, Biosimilar Patents, BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars. Approximately 20% of the Biologics and Biosimilars in the worldwide R&D pipelines are facing challenges to fall in line with the regulatory guidelines.
Track 7: Intellectual Property Rights
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 8: Globalization of Biosimilars
This track discus 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. The global market scenario with the launch of first biosimilar in the market forecasts some radical changes. This track will look upon such key concerns which are witnessed by the global Pharma market and that are coming up with the subsequent launch of the other Biosimilars and Biologics. Despite these emerging facilities, bio therapeutic developers are most comfortable off-shoring to established markets—the US and Europe. In terms of the outsourcing destinations that are most-cited as at least a possibility for outsourcing during the next five years, the leading markets are: USA (78% are at least considering) Germany (76%) Singapore (74%) United Kingdom (73%).
Track 9: Brexit Effect on Biosimilars
The Brexit effect on Biosimilars tends to be negative. Not only would it be a major setback towards approval and launch of Biosimilars to the market but also it would be hindrance towards the cost cutting approach taken up by NHS. With Britain being among principal clinical trial centres is owned to see a decrease in the willingness of the manufacturers and researchers to carry out any further trials in Britain. Also Brexit will cause the principal motive of British Biosimilars Association (BBA) to fall back- which aimed at increasing the use of Biosimilars.
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. Biologics also represent over 40 per cent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages. Biosimilars are surmounting pharmaceutical business division from latest three decades and arrangements seem to expand intelligently. Advances in the biotechnology incite to change and presentation of new natural things (Biosimilars) to treat various life-debilitating sicknesses. Biosimilars are natural solutions that are passed on after expiry of the patent of certified pioneer and incorporate Hatch-Waxman act is the correction to Federal, Food, Drug and Cosmetics act which built up the cutting edge arrangement of approval of generics through Abbreviated New Drug Applications
Track 11: Biosimilars- Legal Issues and BPCI Act
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 12: USFDA Approved Biosimilars
USFDA Approved Biosimilars: In the United States, the Food and Drug Administration (FDA) held that new legislation was required to enable them to approve Biosimilars to those biologics originally approved through the PHS Act pathway. Since 2004 the FDA has held a series of public meetings on Biosimilars.
The FDA has previously approved biologic products using comparability, for example, Omnitrope in May 2006, but this like Enoxaparin was also to a reference product, Genotropin originally approved as a biologic drug under the FD&C Act.
Track 13: Biosimilars Approved in Europe
Biosimilars have been broadly and securely utilized as a part of Europe since 2006. In 2004, the European Commission (EC) passed enactment making a Biosimilars endorsement pathway (Directive 2001/83/EC Directive 2004/27/EC). In 2005 and 2006, the European Medicines Agency (EMA) discharged its first arrangement of biosimilar rules, and in 2006, endorsed its first biosimilar. To date, there have been 14 Biosimilars approved, with biosimilar monoclonal antibodies expected soon. In spite of a thorough observing, following, and following framework, Europe has distinguished no security issues with Biosimilars.
Track 14: Emerging Biosimilars in Therapeutics
The explorations in the field of biologics have created a new avenue for the clinicians towards better disease management. The emerging biologics have already manifested fruitful outcomes in treatment of ailments like those of psoriasis, rheumatic arthritis, certain cancers, inflammatory bowel disease (IBD) etc .Emerging Biosimilar insulin’s are likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. The main theme of this track is to have sound knowledge in the emerging Biosimilars like Filgrastim, Pegfilgrastim, Recombinant blood products, therapeutic proteins, vaccines, Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments and their impacts.