Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.
What do patient groups want from biosimilar manufacturers, and what advice can they give companies to help shape their initiatives to educate stakeholders?
In the first of this two-part article, four patient advocacy groups share the level of knowledge their members have surrounding biosimilars and what types of strategies they have enacted to educate their patients.
During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”
Pfizer's Tracy Dianis presents a candid look into the cognitive and cultural transition that needed to occur in her own mindset, as well as within Pfizer, in order to embrace biosimilar development.
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 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.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?
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.
The ultimate goal of formulation development is a stable product. In the case of a protein product, that can be defined as delivering the correct dose, in the native secondary and tertiary structure, without unintended chemical modifications, and free of extrinsic and intrinsic particles. In many cases, a lyophilized formulation can provide the highest probability of technical success. A well-designed product development plan can develop a phase 1 product quickly, while laying the foundation for commercial product success.
In terms of life sciences, Brazil is best known as a small molecule pharmaceutical market; some of the largest companies in Brazil are small molecule generics companies. But, in recent years, the country has identified the importance of establishing a biotechnology industry. Enter the productive development partnerships (PDPs).
There were two big questions that were addressed throughout the recent World Biosimilar Congress conference that both deepened my own knowledge of this space and/or called attention to topics that have been cropping up in other industry discussions.
A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
It’s unlikely biosimilar applications containing only analytical and preclinical data will meet the FDA’s demands for totality of the evidence within the next few years. However, a changing political climate urging quicker development and lower drug prices has only intensified the discussion within the biosimilar industry about developmental efficiency.
Edric Engert, managing director of Abraxeolus Consulting (formerly of Teva), shares his opinions on where the biosimilar market is heading, how we can promote greater uptake within the U.S., and just how “genericized” the market can and will potentially become.
In the pharmaceutical industry, five years is a short length of time in which to launch a company, establish a development process, and bring several biosimilar candidates to market. In an interview, Paul Song shared some of the efforts Samsung Bioepis has made to pass down lessons learned and to continue evolving in the years ahead.
Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.
The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.
REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.
As Pfizer began its pursuit of delivering two biosimilar monoclonal antibodies (mAbs) in China, it sought a partner that could mitigate the risks of expanding into this region while also significantly reducing the development timeline. By leveraging the expertise of an experienced partner and the benefits of single-use technology (SUT), Pfizer was able to quickly establish a global footprint while also gaining a competitive advantage in an emerging market.
AmerisourceBergen's Dave Picard, VP of biosimilars and injectables, offers valuable insight into current market dynamics and how biosimilars will fit into current hospital distribution models.
I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.
A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.