Martin Van Trieste
Senior Vice President of Quality
As anticancer antibody therapies have evolved into ever more highly engineered and complex structures, so have the manufacturing processes that pave the way for their widespread clinical use.
Today, many of the most widely used oncology drugs are biologics, broadly defined as agents produced from living organisms rather than chemical synthesis. By 2016, eight of the top 10 best-selling drugs worldwide for all disease states including cancer are expected to be biologics, industry analysts predict.1
The expanding use of these therapeutics has prompted much debate about biosimilars, which are versions of original, proprietary drugs but differ sharply from traditional generics in part because biologics are developed from unique cell lines. Although the FDA devised a pathway for biosimilars last year, Fitch Ratings analysts believe biosimilars approved through those regulations will not be launched in the United States before 2015 and that it will take several additional years for the market to develop more fully.1
Against this backdrop, Amgen has been vigorously reaching out to practicing oncologists, hematologists, and pharmacists to demonstrate and explain its manufacturing processes. The company showcased its technology at the 2013 American Society of Clinical Oncology Annual Meeting in June with interactive displays of the multifaceted process of developing biologics from cell lines to distribution. That marked the debut of an educational website, www.biotechnologybyamgen.com
Amgen’s portfolio includes several biologics used in treating patients with cancer, notably pegfilgrastim (Neulasta), filgrastim (Neupogen), panitumumab (Vectibix), and denosumab (Xgeva).
Last year, the company announced plans to develop and commercialize “on a worldwide basis” biosimilar versions of other branded drugs, including bevacizumab (Avastin), trastuzumab (Herceptin), rituximab (Rituxan), and cetuximab (Erbitux).2
In an email interview with OncologyLive
, Martin Van Trieste, senior vice president of Quality at Amgen, discussed some of the key issues involved in the manufacture of biologics.OncologyLive: With the website unveiled at ASCO, Amgen seems to be making a concerted effort to reach practicing oncologists and hematologists with information about the company’s processes for manufacturing biologics. Why has Amgen taken this approach?
As countries around the world confront aging populations with increasing rates of chronic disease, a reliable supply of high-quality medicines, including biologic medicines, has never been more important.
Even small variations in the complex biologics manufacturing process can potentially alter safety and efficacy of these medicines. It takes considerable expertise, experience, and investment to ensure reliable supply of biologics for patients.
Through Biotechnology by Amgen
, we are highlighting Amgen’s commitment to its goal of reliably supplying quality medicines and its investment in manufacturing processes and key practices that have helped Amgen to avoid drug shortages (as defined by the FDA) of its own medicines.
Expertise, experience, investment, and track record should be considered by all those involved in the provision of biologic medicines.What is important for US oncology specialists to know about the manufacture of brand-name biologics and biosimilars?
Over the years, it has become evident that even organizations with significant expertise and manufacturing experience can face hurdles in dealing with the inherent complexity in producing biological medicines.
Maintaining a consistent supply of safe and effective biological medicines requires expert staff, advanced science, and sophisticated technology throughout the manufacturing process and supply chain. It also requires high standards for compliance with regulatory requirements and an organizational culture that values quality.
To put this into context, between 2005 and 2016, Amgen expects to invest approximately $1.5 billion in numerous strategies to help ensure that high-quality biologics get to the patients who need them. We are also leading the way forward to the next generation of biotech manufacturing, which includes a $200 million investment in a new, world-class manufacturing facility in Singapore as part of our Manufacturing of the Future (MoF) initiative.Do you foresee a time when prescribing physicians, particularly those who treat patients with cancer, will want or need to evaluate the source of a biologic medicine before prescribing it? That is, will they want to make a value judgment on the manufacturer and, if so, what mechanisms would they use for going about it?