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.
In the last decade, the healthcare industry has witnessed significant changes, some of which present important challenges to how pharmaceutical companies develop drugs. One such challenge is the shift in influence from the physician to the payer in the adoption of new interventions. This article discusses threats to the traditional model of drug development posed by the increasing influence of payers and considers ways for industry to embrace “value-focused development” to simultaneously adapt to the evolving market and de-risk drug development.
The first installment in this two-part series examined rising costs associated with orphan drugs and two related case studies. This second part provides actionable suggestions for developers.
On June 12, the Supreme Court issued a unanimous opinion in Amgen v. Sandoz, penned by Justice Clarence Thomas. The Court addressed two questions, stemming from the Federal Circuit’s 2015 decision in the case, on which certiorari had been granted.
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).
In our studies we asked respondents to indicate their facility’s primary objectives for biologics production today and in 10 years. We found that in China, 70 percent of biopharma facilities today are primarily focused on production for domestic consumption.
In this article (the second of two parts), experts from a regional and national payer elaborate on some of their expectations for the market and how they — in partnership with companies — can encourage biosimilar acceptance.
In the first of this two-part article, two experts from a regional and national payer reveal why they haven't exactly taken the hoped-for no-holds-barred approach to biosimilars.
State lawmakers continue to spearhead legislative boundaries to automatic biosimilar substitution at a rapid clip across the nation, with 33 states and Puerto Rico having taken action and with bills pending in eight more states.
A recent discussion amongst experts from Momenta, Eli Lilly, and Foley & Lardner highlighted the diversity of opinions surrounding Amgen v. Sandoz and other legal challenges in the space. But lurking underneath discussions of statutes and standards of evidence is biosimilar makers' desires for options to address the U.S.' rigid patent landscape.
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?
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.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
To allay fears about manufacturing changes, valuable tools are now in places by the FDA to facilitate these transitions. By not understanding the availability and value of these resources, manufacturers are making a sizeable mistake that could potentially impede the industry’s passage into the next phase of modernized manufacturing.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.
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