Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?
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.
This article examines Thailand's history with biologics and biosimilars, as well as Siam Bioscience's perceptions of the current Thai FDA biologics and biosimilar regulations in relation to the U.S. and EU.
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.
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.
Despite the many positive steps we’ve taken to establish the biosimilar industry today, it seems as though the success of the biosimilar market in the U.S. is still looking hazy. Every conference I’ve gone to has focused on the challenges facing the industry and concerns over the different regulations being established. But CBI’s 12th Biosimilars Summit felt particularly realistic in how it approached those issues.
Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”
In the face of patient and physician hesitance about the safety and efficacy of biosimilars, long-known innovator company brands reassure stakeholders of the company’s experience, quality, and reliability. But this begs the question, how do smaller biosimilar companies fit in?
Though there is already a vast amount of available biosimilar-related real-world evidence (or Big Data), the industry will face quite a few pitfalls in securing and interpreting this data.
Real-world evidence, or data from real-world practice and use outside of clinical trials during drug development, is steadily becoming a key complement to randomized clinical trials. As Quintiles' Nancy Dreyer said, “So far, we’ve been concentrating on how biosimilars are made and how they will affect patients. But we need to be thinking bigger.”
In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
A few weeks ago, I sat in on a webinar hosted by ProCE called “Biosimilars Out Of The Gate: What Are the Latest Developments?” Though the webinar was not directly targeting companies developing biosimilars, I felt some of the insights carried important implications for biosimilar makers.
In February 2016, InCrowd surveyed biologics-prescribing physicians in the U.S. to determine their views on prescribing biosimilars. In September 2016, InCrowd held a follow-up survey to determine how, or if, physicians’ thoughts had changed over six months. Some of the results might surprise you.
In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries.
Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls.
Commercialization is one of the hottest topics of discussion in the biosimilar industry, perhaps because, so far, the path to commercial success is far from black and white.
In August 2016, India’s Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology revised the September 2012 Guideline for Similar Biologics. The revision was done to keep pace with ever changing global standards and to streamline the regulatory process for the authorization of biosimilars in India. What do biosimilar makers need to know?
As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.