14^th European Biosimilars Congress April 28-29, 2021 London, UK

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. Disease 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.

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%.

Clinical trials for biosimilars must exhibit practically identical security what's more, viability to the reference item, including consecutive PK/ PD and viability/security trials. Controllers expect PK/PD similarity information from a Phase I trial will bolster encourage viability/ wellbeing evaluations in crucial Phase III trials. Remain solitary Phase III investigations or joined Phase I/III outlines without supporting PK information are probably not going to be acknowledged. Clinical similarity prerequisites may fluctuate on a case-by-case premise subject to a risk based approach. Three-arm Phase I trials are progressively being used to show equivalence between the biosimilars and two authorized adaptations of a similar reference item that may exist in various markets, allowing developers to proceed with pivotal trials using a single version of the reference product

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 biosimilars conference will look at the multiple facets of current challenges in Biosimilars development. This biosimilars conference will focus on multiple aspects of biosimilars product development to successfully deliver safe, potential and efficacious biologic products to the market.

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.

Competitions and/or success in the present pharma industry are determined by the winning patent strategy which mostly pertains 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.

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.

A Biosimilars bio therapeutic item is comparative (but not identical) as far as quality, wellbeing, and viability to an effectively authorized reference item. Not at all like nonspecific little particles, it’s hard to institutionalize such naturally complex items in light of convoluted assembling forms. The worldwide biosimilars advertise is developing quickly as licenses on blockbuster biologic medications terminate and other medicinal services parts centre on lessening of expenses. Biologics are among the most elevated cost medicines on the worldwide market today, which suggests the requirement for minimal effort choices. In developing markets, biosimilars officially offer more moderate costs, which are alluring, as well as crucial to economies where costly medications are not monetarily achievable

Biological medicines are much more structurally complex and extremely sensitive to manufacturing conditions and therefore more difficult to characterize and produce than small molecule drugs. Even minor changes in manufacturing may lead to significant variations of the cellular systems used for biological production, as well as to differences in the structure, stability, or other quality aspects of the end product, all of which have the potential to affect tolerability and/or efficacy and increase the risk of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there is some disagreement on which studies need to be implemented to approve a biosimilars. According to current literature, the following points on biosimilars deserve consideration: Biosimilars development is characterized by global harmonization, although several not fully answered questions remain regarding extrapolation of indications, switching or interchange ability, and tolerability; in patients with rheumatic diseases, the tolerability and efficacy of biosimilars in clinical practice remain to be established; several medical and patient associations have published position papers on biosimilars requesting that safety, efficacy, and traceability be carefully considered; long-term post marketing studies should be implemented to allow physicians to gain confidence in biosimilars.

Biopharmaceutical informatics endeavors to use information technology, sequence-and structure-based bioinformatics analyses, molecular modelling and simulations, and statistical data analyse towards biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence

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.

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 and in vivo correlation achieves the required degree, the biosimilars 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 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​velopment 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. 

This session of the Biosimilars 2018 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.

The legal issues pertaining to 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.