Issue link: https://www.e-digitaleditions.com/i/1211868
6 BioPharm International eBook February 2020 www.biopharminternational.com Partnerships for Outsourcing Cover Story finish operations appear to be con- tracting slightly over the past five years, from a high of 27.8%, indi- cating an decrease in outsourc- ing, to 19.7% this year who plan more fill/finish outsourcing over the next two years. Downstream process development is on the rise in terms of outsourcing trends. Validation services, on the other hand, have declined somewhat over the past nine years." Khalafpour sees strong growth in mammalian-derived molecules, which may require the ser vices CDMOs can provide. "Based on market assessment, mammalian appears to remain the preferred production technology with the highest growth potential due to pipeline increase and improve- ments i n ma nu fac t u r i ng tech- nolog y," says Khalafpour. Small and virtual biotech companies are expected to own these molecules, accord i ng to K ha la f p ou r, a nd these companies may not have the expertise or services needed to produce these products. "In addi- tion, the development and man- ufacturing of biopharmaceuticals is getting more complex in terms of production processes and reg- ulatory environment while fore- casting remains uncertain," says Khalafpour. L o n z a h a s a n n o u n c e d t h e a c qu i s it ion of a s te r i le m a n - u f a c t u r i n g f a c i l i t y i n S t e i n , Switzerland for clinical produc- tion and commercial launch of pa rentera l d r ugs, accord i ng to Khalafpour. The company is also building a development and man- ufacturing facility in Gaungzhou, China. ON THE HORIZON Development of new and more complex molec ules are in store for t he i ndust r y, accord i ng to Khalafpour. Clark sees biosimilars as the next trend in outsourcing because of the amount of inno- vator products coming off patent and the unique needs associated with analytical testing. The prom- ise of next-generation biologics is also becoming ev ident, accord- ing to Clark. "Mid/large pharma companies are taking notice and acquiring companies and mole- cules to expand their pipelines. The shift in focus to these new therapeutic classes may impact t he t y p e s of prog r a m s t hat a s p on s or c omp a ny out s ou r c e s . For example, they may choose to outsource the manufacturing of monoclonal antibodies or recom- binant proteins that they had pre- viously manufactured in-house to free up internal resources to focus on their next-generation thera- pies," says Clark. K halaf pour agrees. "As far as drug manufacturing is concerned, we see smaller production vol- umes driven by personalized med- icines, highly active compounds, [and] higher titers as well as con- tinuous manufacturing and pro- cess intensification." REFERENCES 1. Brett P. Giroir, "Statement on Efforts to Help Make Development of Biosimilar and Interchangeable Insulin Products More Efficient," FDA.gov, Nov. 25, 2019. 2. GlobalData, PharmSource–Gene Therapy Market Opportunity for CMOs– 2019 Edition, December 2019. 3. BioPlan Associates, 16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (BioPlan Associates, Inc., April 2019). BP FDA and FTC collaborate on competitive biologics market On Feb. 3, 2020, FDA announced that it is working with the Federal Trade Commission (FTC) in a joint effort to ensure a robust marketplace of biological products. The agencies will work to deter anti-competitive behavior in the biosimilars market. Biosimilars of FDA-approved reference products may reduce healthcare costs, according to FDA, and the agency has been taking steps to promote the growth of the biosimilars market. The industry, however, has seen some pharmaceutical manufacturers of reference products participate in anti-competitive behavior. This behavior may include making false or misleading statements about biosimilars, which could have a negative impact on the perception of the efficacy and quality of approved biosimilars. FDA and FTC will be collaborating on public outreach efforts to bring industry, academia, and government agencies together to discuss competition in the biosimilars market. The agencies will discuss best practices for preventing anti-competitive behavior, and FTC will review patent settlement agreements that involve biosimilars. FDA is publishing guidance on the presentation of data and information about biosimilars and reference products in FDA-regulated promotional materials. The guidance will answer questions about the development of promotional materials and provide examples of situations involving the promotion of biosimilars and reference products. —The Editors of BioPharm International