4th International Conference and Exhibition on Biologics and Biosimilars October 26-28, 2015 Baltimore, USA

OMICS International is organizing 4th Biologics and Biosimilars Conference during October 26-28, 2015 Baltimore, USA. (Biosimilars 2015)

OMICS International Organizes a 300+ Series Conferences  Every Year across USA, Europe & Asia with support from 1000 more scientific societies and Publishes 400+ Open access journals which contains over 30000 eminent personalities, reputed scientists as editorial board members.

Biosimilars is a global annual event. This Biosimilars 2015 brings together scientists, researchers and CROs from around the world. Biologics are a highly-effective class of medicines that are based on naturally occurring proteins and produced using living cells. Many biologics are produced using recombinant DNA technology.

There are about 193 companies of Biologics and Biosimilars in USA with 35,000 entrepreneurs working on these topics. All over the world, there are more than 380 companies producing Biologics and Biosimilars and 55,000 industrialists doing their research work.

The global biosimilars market is expected to reach $19.4 billion by 2014, growing at an Annual Growth Rate (CAGR) of 89.1% from 2009. By 2020, the global market for Biosimilars will be reaching $55 Billion. Biologic agents will continue to outpace overall pharma spending growth and are expected to represent 19-20% of the total market value by 2017. USA is leading its position in Biologics production and sales followed by European countries. Uptake of Biosimilars is more in European countries followed by China.

For more information, please visit: Biosimilars Market Analysis

Track 1: Challenges and Regulatory Approach for Biosimilars

Biosimilars-the generic version of biologicals is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals.

World Biosimilar Congress 2015  will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics.

Track 2: Emerging Biosimilars in Therapeutics

Biosimilar insulins are likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. Biosimilar insulins have the potential to reduce diabetes treatment costs, increase the accessibility of insulin treatment, and expand the number of biosimilar insulin brands available for those with diabetes. However, they will have to overcome numerous regulatory hurdles, meet a variety of commercial demands, and effectively confront competition from both established and next-generation branded insulin products before they can succeed on the global market. This biosimilars meeting shall be the perfect bridge between the renowned academicians and industry personalities to pave the way for biosimilar insulins in the market.

The main theme of this track is to have sound knowledge in the emerging biosimilars like Recombinant blood products, therapeutic proteins, vaccines,Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments.

The sub tracks included in this are Biosimilars in cancer treatment, Biosimilar monoclonal antibodies, Biosimilars interferon, Biosimilars in rheumatic diseases, Biologics in autoimmune disease, Biologics in cardivascular diseases.

Track 3: Clinical Studies and Clinicians Prospects for 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.

In this track is designed for those who are having sound knowledge on clinical studies and clinicians prospects for biosimilars.Biosimilar guidelines on the above mentioned topics are also to be thrown light upon in this session.

Track 4: Emerging Biologics in Therapeutics:

The explorations in the field of biologics has created a new avenue for the clinicians towards better disease management. The emerging biologics has already manifested fruitful outcomes in treatment of ailments like those of the biologics in  psoriasis,biologics in rheumatic arthritis,biologics in cancer, biologics in inflammatory bowel disease(IBD) etc. Biologic agents like Ustekinumab and Secukinumab has already produced promising results. Thus follow-on-biologics have a great prospect to find a prominent space in treatment protocol of these disease and also with better patient compliances.

Track 5: Globalization of Biosimilars:

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

Those who can attend the biosimilar exhibition under this track are ones following Biologics/ Proteins/Biosimilar Products, New Biosimilar Development, Process Science,Biosimilar Market, Portfolio Management, Research & Development, Business Development, Business Operations and Scientific Affairs.

Track 6: Biosimilars Innovator Pharmaceutical Products:

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original biosimilar "innovator" products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Also includes Biotechnology medicinal products for different drugs, Future of next generation biosimilars, Biopharmaceuticals development.This session shall be highly beneficial for the biosimilar manufacturers. This session also finds place for all the biosimilar exhibitions associated with the field of biosimilar and biologics.

Track 7: Biosimilars Analytical Strategies:

Analysis of biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. 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.

Effective management of a good manufacturing practice (GMP) facility requires a keen 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.

Track 8: Bioequivalence Assessment:

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 also includes Strategies for the bioequivalence assessment of topical dosage forms,  Bioequivalence assessment of respiratory dosage forms, Bioequivalence approaches for transdermal dosage forms.

Track 9: BCS and IVIVC Based Biowaivers:

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.

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. The biosimilar conferences 2015 aims at addressing all such challenges of the pharma formulation sector.

Track 10:Plant Produced Biosimilar Products:

Biosimilar products are also produced from plants, Production of Biosimilar products in tobacco plants completion of the first step in their research. These also includes Transgenic plants, Post translational genetics, Fermentation culture, Molecular farming. For biosimilar manufacturers this session has the potential to bring up new avenues in their product range.

Biosimilars conference is expected to be the best platform for the scientists to share scientific knowledge amongst those biosimilar companies and research institutes who are engaged in biosimilar development pertaining to plant source biosimilars.

Track 11:Pharmacovigilance and its Challenges:

This session of the Biosimilars 2015 looks into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.

Track 12: Biosimilars Regulatory Affairs and Intellectual Property Rights:

Needless to mention differentially that any pharma product has to successfully pass through the regulatory affairs' scanners before being launched in the market. Biosimilars and biologics are no exceptions. Apart from regulatory aspects the companies developing these biosimilars and biologics tend to enjoy monopoly over their product. Intellectual Property Rights(IPR) and patents are ultimate tools to the biosimilar manufacturers for safeguarding their interests.

Pharma patent scenario, Criteria for patentability and patent claims, Patentable subject matter, biosimilar guidelines,biosimilar patent issues are key points of discussion in the segment.Patent analysts, law firms and legal authorities dealing with biosimilar regulatory affairs would find this conference a perfect platform to put forward their views on the topic.

Track 13: Current Challenges in Advancement of Biologics

Current concepts of drugs and biologics, Unique considerations for biologics, Early clinical development essentials, Cancer therapeutics, Comparability for Biologics, Biosimilar approvals are the points of discussion in this session.

This biologics conference 2015 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. Hence, this 4^th international Biosimilar Conference will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscapes, biosimilar guidelines to the legal and economic aspects and current challenges in biosimilar development, . This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, biosimilar products to the market place. By attending this biologics conference,USA you will gain a comprehensive outlook on the key issues surrounding biosimilars. This event will provide an important platform for Biosimilars stakeholders to discuss and share best practices in expediting development in Biosimilars 2016 and onwards.

The Europe biosimilars, US biosimilars, Australian biosimilars, Canada origin biosimilars and UK biosimilars are expected to take control over the biosimilar market around the globe by 2017.