13^th Asian Biologics and Biosimilars Congress July 26-27, 2019 Melbourne, Australia

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 drug qualifies to be a suitable biologics or biosimilars.

Biosimilars are the generic version of biological. It 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, Biosimilars regulatory prospects of BRIC countries, a paradigm of traditional generics to Biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. Biosimilars 2018 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 with a clear picture of the regulatory approach for biosimilars and biologics. 

A biopharmaceutical is also known as a biologic(al) medical product. It is any pharmaceutical drug product which is manufactured in, extracted from, or semisynthesized from biological sources. They are different from totally synthesized pharmaceuticals. They include vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy.

This session of the Biosimilars 2018 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.

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, PK/PD studies, Toxicological studies, ethics maintained in clinical and preclinical studies, development difficulties and Aspects of genotoxicity tests. Biosimilar guidelines on the above mentioned topics are also to be thrown light upon at this biosimilars conference.

 

 

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.

 

This track includes Clinical Studies & Trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, 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.

The generic version of Biologicals- “Biosimilars” is the new buzz word in the world of pharmaceutical industry. Biosimilars are highly similar to their licensed reference product not withstanding minor differences as excipients in the formulation; also there are no remarkable differences between the Biologicals and the reference product in terms of safety, purity, and potency. However, there are certain challenges in way of its development and receiving a green signal for launching into the market. Newer biologics also are targeting widespread diseases, with profound implications: a drug that costs $20,000 per year that is useful for 1 person in 100,000 has much less effect on a health plan’s cost structure than a $5,000-per-year drug that is useful for 1 in 100 people.

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. Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in Pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

A biosimilar is an organic item very like an affirmed natural item, known as a kind of perspective item, with no clinically significant contrasts as far as wellbeing and viability. In the U.S., if a natural compound exhibits practically identical information to a U.S. Nourishment and Drug Administration (FDA)- authorized item from expository, preclinical and clinical reviews, it will be acknowledged as a biosimilar after termination of trend-setter licenses through a curtailed course. Tradable natural items are likewise Biosimilars, however should meet extra criteria to coordinate the reference item. Interchangeable can be substituted for the reference item without a medicine from a social insurance supplier.

The development of biologics calls for overcoming lot 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 Euro Biopharma 2017 conference will look at the multiple facets of current challenges in biosimilar development. This conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.

Good Manufacturing Practices quality of drugs is essentially the responsibility of manufacturers. GMP Guidelines are means to assure this very quality of drugs. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. GMP is actually good common sense quality management quality assurance GMP production and quality control.

Products that are obtained from specific organs or tissues said to correspond with the unhealthy organs or tissues of the recipient. Proponents claim that the recipient's body automatically transports the injected cells to the target organs, where they supposedly strengthen them and regenerate their structure. The organs and glands used in cell treatment include brain, pituitary, thyroid, adrenals, thymus, liver, kidney, pancreas, spleen, heart, ovary, testis, and parotid. Several different types of cell or cell extract can be given simultaneously - some practitioners routinely give up to 20 or more at once.