In the first of this two-part article, Sandoz's Cindy Cao shares lessons learned from working with the FDA and reveals that there is still a lot of room for exploration and innovation in biosimilar development.
I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.
Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.
In a presentation at the 2017 World Biosimilars Congress, Asif Mahmood, disease area safety and strategy lead at Pfizer, shed some light on global risk management strategies and the challenges of launching these programs.
In a recent article, I discussed the market opportunities and reimbursement system in Russia. But in addition to this snapshot of the market, my conversation with BIOCAD's Roman Ivanov highlighted how the Russian biosimilar regulatory system was established, as well as the challenges BIOCAD has faced during it evolution.
After my discussion with BIOCAD's Roman Ivanov, it’s clear the Russian biosimilar market is a prime example of the positive impact biosimilars can have on a nation. However, Russia's biosimilar market has evolved quite differently than those of the EU and U.S.
In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.
There is no cut-and-dried approach to launching a biosimilar globally. It comes down to having the right commercial model for the right product in the right channel in the right market. But knowing what is “right” will be a particular stumbling block for many companies.
As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.
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