The biosimilar market is projected to grow significantly. What are the key drivers behind this rapid growth, and how do you see the market evolving over the next decade?
The market need is the main driver. Today, access to quality Biologics drugs is limited to a minority of the patients around the world. Increasing the supply of biosimilars worldwide should contribute to making Biologic based treatment more available.
Regulatory pathways for biosimilars vary globally. How do these differing regulatory environments impact biosimilar development and commercialization strategies?
Entering the highly regulated market (North America, Europe, Japan, and Australia) is more challenging than entering less regulated markets. Depending on the location of the biosimilar development companies, they may choose an easy route to market their products. But today we see more and more development of biosimilars that meet FDA and EMA eexpectationspartially because the regulations have eased to allow faster and less costly development. Ultimately, this will allow the availability of more affordable medicine for patients.
Manufacturing biosimilars presents unique challenges. What technological advancements or strategies are emerging to address these hurdles and make biosimilar production more efficient?
Developing a Biosimilar without involving the use of innovation in all steps of the production will result in a moderate price cut for the drug. Increasing production yield is essential. Continuous production is one approach amongst others that could lead to a substantial reduction of the production cost of the Drug Substance. Optimization of the downstream steps, as well as the use of disposable bags for the upstream phase, have to be considered when developing a biosimilar.
The adoption of biosimilars varies significantly across therapeutic areas and regions. What factors contribute to these differences, and how can stakeholders promote wider acceptance and utilization of biosimilars?
In some countries, there is no choice, the cheapest drug (biosimilar or originator) will have exclusivity in the market. I believe that information regarding what is a biosimilar should be widely given to payers and medical doctors so that they will feel confident to prescribe biosimilars. Pharmacovigilance results of the biosimilars should be made more accessible.
As the biosimilar landscape becomes increasingly competitive, how are companies innovating their commercial models, portfolio management, and speed-to-market strategies to maintain a viable business in this rapidly evolving sector?
Innovation is key to developing a biosimilar. The developer should be focused on the biosimilar as developing a biosimilar requires a mindset that is different tfromthe mindset required to develop an originator drug. Developing a process to produce a biosimilar to EMA/FDA standards and then licensing the process to various regions of the world will allow a reduction of the costs of the development (it will be done once) and will give each region health sovereignty which ultimately will guarantee the quality, the cost control, and the supply of the medicine.
Author Details
Dr. Luc-Alain Savoy- Global Head of Biologics, SGS
Publication Details
This article appeared in American Pharmaceutical Review:Vol. 27, No. 7Nov/Dec 2024Page: 58
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from American Pharmaceutical Review delivered to your inbox!
Sign up now!