6^th International Conference and Exhibition on Biologics and Biosimilars October 19-21, 2016 Houston,Texas, USA

The main theme of this track is to have sound knowledge in the emerging biosimilar products like Recombinant blood products, therapeutic proteins, vaccines, Growth hormones, Biosimilar peptides, therapeutic proteins, biosimilar antibodies.Biosimilar insulins are the most expected ones in the class to enter the biosimilar landscape as patents for major branded insulin products start to expire in the next few years

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%.

Effective management of a current good manufacturing practice (GMP) facility requires a strict eye on all those factors. This also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.Analysis of Biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process.

Amongst all challenges biosmilar analytical startegies are the ones that occupy 20% of all other challenging parameters. Analysis of biosimilar and biologics thus takes the longest stretch towards establishing the product in comparison with the original product.

World Biosimilar Congress 2016  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..

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.

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.

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.

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, biotherapeutic 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%).

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 percent of the drugs in each of the preclinical, Phase I, Phase II, and Phase III trial stages.

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.

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.

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.

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%.

This session of the Biosimilars 2016 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 comparitively more than other pharmaceutical products.

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 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 centers 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 Bristish Biosimilars Association(BBA) to fall back- which aimed at increasing the use of biosimilars.