Emerging Trends in Biosimilars
Dr Sudheer Balaraju
Head - Medical & Safety
Navitas Life Sciences

Swetha R Khokale
Head Project Management - APAC
Navitas Life Sciences

The success of innovator biologicals with downsides of high costs and patents expiring have contributed to development of Biosimilars coupled with advantage of regulations, adaptability by physicians and patients. Biosimilars being complex molecules need to have sound scientific strategic approach to development, manufacturing and research. Few legal issues have not dampened Biosimilar companies to have strong pipelines, quality and focused timelines to provide affordable and effective drugs to patients in need.

Biosimilars - The generic version of biologicals is not only an emerging trend but has paved its way to succeed and sustain in the world of pharmaceuticals. Biosimilars take credit for revolutionizing the development of targeted, effective and affordable biologic treatments required across various therapeutic areas like Oncology, Immunology, Endocrinology, Ophthalmology etc. This need has attracted major investors as the prospects are driven by streamlined regulatory guidelines with high adoption rate amongst physicians and patients.

At Navitas Lifesciences, as a global CRO, we have been working with various global and regional Bio-pharmaceuticals companies on their innovative biologics and biosimilar projects. Over the years, this experience has leveraged us to understand and appreciate the contribution of biosimilars right from the clinical development at Sponsor's end to complexities in study conduct, receipt of regulatory approval and finally being able to witness the much-neededaccess and benefit to patients.

Biosimilars, as we know are highly similar to their licensed reference product in terms of quality characteristics, biological activity, safety, and efficacy. Unlike small molecule (chemical) drugs that can be fully defined structurally, biologics exhibit high molecular complexity which are isolated from natural sources and sensitive to changes in manufacturing processes that contribute to certain challenges in its development and receipt of marketing approval.

Innovator biologics have no doubt proven efficacy, safety and have contributed to several unmet medical needs, however high costs and affordability of these drugs cannot be discounted. As the patents and exclusivity for many biologics are expiring, this has created the huge opportunity for the development and approval of biosimilars for many biopharmaceutical players including innovator generics and biotech companies . The Global Biosimilars market is expected grow at 23 % CAGR over 2017-2023 , from USD 4.10 Billion in 2017 to USD 14.23 billion by 2023.

Biosimilar regulatory guidelines are evolving globally, European Union (EU) is more matured has biosimilar guidelines since 2005 followed by Taiwan, Malaysia, Australia, Japan, Korea, Canada, Brazil, Mexico, India and including USA, first biosimilar was approved by US FDA in March 2015.

It is essential to have proper scientific, strategic approach with adherence to "Quality by Design" for the successful development of biosimilars. The need for overcoming challenges continues to the late clinical steps including drug safety factors and labelling requirements.

Manufacturing processes for biosimilars have an independent design and need not duplicate the originator's production methods. Instead, the focus is on extended characterization efforts to show that the biosimilar is 'highly similar' to the reference drug. That contributes significantly in reducing clinical efforts and costs for the biopharma's. Effective management of Good Manufacturing Practice (GMP) facility is critical and requires vigilance throughout. Analysis of biosimilars and biologics are one of the most important aspect towards the biologics and biosimilar development process and hence again critical while designing the study protocol.

Some of the emerging biosimilar products are recombinant blood products, therapeutic proteins, vaccines, growth hormones, biosimilar peptides, therapeutic proteins, monoclonal antibodies (mAbs) etc. 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.

One aspect that cannot be ignored are legal issues pertaining to biosimilars which is the need of the hour to be addressed by regulators. Unfortunately, in some cases, before the actual advent of biosimilars to the market, legal issues have risen during their developmental stages itself. Well known pharma companies have filed cases against each other to claim their rights and for other legal allegations related to the products.

That said, there is no stopping of biosimilars with several big and small biopharma's of investing in a future pipeline. Time is of essence and is the game changer. Biologics/Biosimilars represent over 40 per cent of the drugs in Preclinical, Phase I, Phase II, and Phase III trial stages and as a CRO, we are always excited to work on biosimilars as they are focused, time conscious, quality driven and in almost all cases give us the gratification of witnessing its success and access to patients.