By: Patti Seymour (pseymourbptccom)
Healthcare.gov has been getting plenty of attention lately in the battle over the future of health care in the United States; however, there are other smaller, though not necessarily less important, battles being fought at the state, federal and global level as multiple parts of the Patient Protection and Affordable Care Act (PPACA) are slowly implemented.
The Biosimilar Price Competition and Innovation Act (BPCI Act), part of PPACA, is having some less headline grabbing battles as well as its implementation progresses. Skirmishes at the state level have occurred over how easily pharmacists can substitute a less expensive biosimilar for a brand-name biologic product if the FDA approves the biosimilar as “interchangeable.” Many US states are considering, or have introduced, laws related to the substitution of biosimilars at the retail pharmacy level that would require pharmacists to inform the patient’s doctor whether a biosimilar or brand-name drug was dispensed and if a substitution was made. Even though these bills would affect only a small percentage of biologic drugs that are dispensed through retail pharmacies, like Enbrel and Humira, the battle lines have been drawn, as seen recently in California. The California State Assembly voted in favor of this type of biosimilars legislation, but Governor Jerry Brown vetoed it. This was just part of a larger trend where health insurers and generic drug companies have triumphed in most states over brand-name pharmaceutical companies.
The battle is now shifting to a federal and global stage to determine whether biosimilars will have the same International Nonproprietary Names (INN) as the brand-name product. If they do not, pharmacists cannot substitute the biosimilar for the brand-name product, even if states allowed it. The World Health Organization (WHO), which oversees INN assignments, recently held a meeting where delegates called for biosimilars to be assigned the same INN as their brand-name reference product. Dr Sumant Ramachandra, Senior Vice President and Chief Scientific Officer, Hospira, pointed out that “Europe has approved biosimilars with the same nonproprietary names as their reference biologics for more than six years in a system that has proved effective.” In fact, European Union legislation requires biologics to be identified through both brand name and batch number, and not to rely solely on a unique INN differentiator. To further bolster the biosimilar naming cause, a bipartisan group of US senators sent a letter to FDA expressing their concerns on the issue of naming of biosimilars.
So, why does all this matter? With billions of dollars at stake, slowing down biosimilar use by making it more cumbersome for pharmacists to substitute less expensive versions of a biologic or by advocating for different INNs, which may call into question the safety and efficacy of the biosimilar, can extend the enormous revenues from these products for a few more years. However, Markets and Markets, a Dallas-based research company, forecasts the biosimilar market value to be $1.954 billion by 2018. Europe has about 40% of the market, while Asia-Pacific commands 29% and is considered the fastest-growing, until the U.S. market takes shape. As the US senators stated, “if biosimilars are unable to share the same active ingredient name as the brand originator product, …the intent behind the BPCIA would be undermined as would the safety and accessibility of affordable biosimilars.” In this case, we side with WHO and the senators, and agree that there is much to a name. Sorry, Shakespeare.
By: Patti Seymour (pseymourbptccom)
While global biologics sales are forecasted to surpass $200 billion by 2020, the biosimilars market may only reach $1.9 to $2.6 billion by 2015 , despite the fact that the biosimilar market is touted to be the fastest-growing segment of biologics once biosimilars takes hold, according to IMS Health. We may be witnessing the beginning of that market ramp-up in biosimilar sales with Hospira’s recent EU approval of Inflectra, a biosimilar of Remicade – the first European approved monoclonal antibody biosimilar therapy.
As many companies compete for a piece of the biosimilar market, forecasting the overall demand and the corresponding manufacturing supply capacity required to manufacture biosimilars will be challenging. To manage the risk of this capacity uncertainty, many biosimilar developers are outsourcing their manufacturing. We recently conducted a bioPULSETM survey to explore the effect of biosimilar development on overall outsourcing and manufacturing capacity in both established and growth markets.
There appears to be a wide range of opinions among the survey respondents regarding the effect that the increasing numbers of biosimilars will have on capacity. BPTC understands the concern for a potential capacity shortage is real, however we do not believe that biosimilars alone will cause a capacity shortage. There are relatively few biosimilar products in development compared to the number of innovator products in development, titers continue to increase and in regulated markets, demand for biosimilars will likely erode demand for existing products. So, we do not expect biosimilars will have a significant impact on global capacity demand.
While available capacity may or may not be an issue, demand for commercial manufacturing was the most important factor for the survey respondents. Who can forget the shortage of manufacturing capacity that sent shockwaves through the biotech industry – when Immunex’s capacity shortage for manufacturing Enbrel caused a rationing to rheumatoid arthritis patients because of the unexpectedly high demand?
Interestingly, to help manage access to capacity, roughly 33% of the respondents do not plan to use CMOs because they either already have or will have their own capacity to develop and manufacture their biosimilars. This manufacturing strategy suggests that many companies may be leveraging existing, or building additional, assets to control the development and cost of their biosimilars pipeline.
For those who will use CMOs for their biosimilar manufacturing, a strong majority indicated they would seek CMOs with global regulatory compliance records. This approach indicates that many biosimilar developers will be targeting multiple geographic regions, as opposed to just a few countries, for approval and sale of their biosimilar products. From a business perspective, this is a logical strategy to leverage the relatively fixed CMC costs across as many countries as possible.
In contrast, there is a small cohort of companies that are targeting a regional CMO strategy for biosimilar development. This strategy can offer substantial opportunities for developing biosimilars for growth markets, such as China or Brazil, where there is significant unmet medical need for these products, and the regulatory hurdles are perceived to be lower than other parts of the world. We may even see a shift in the next five years in the percentage of biosimilar developers seeking CMOs with global regulatory compliance records to this regional approach considering three quarters of the respondents indicated that they either plan to increase or keep the same their outsourcing to CMOs in emerging markets. This shift may indicate that companies are beginning to take advantage of incentives offered by some countries to manufacture drugs within their borders or are planning to develop a biosimilar for a limited geographic region.
Nearly 25% of respondents have an alternative biosimilar sourcing strategy which does not involve the use of growth market CMOs within the next five years. This strategy could indicate that companies are establishing centers of excellence for global supply of their biosimilar products, which would not be located in an emerging market, but may still supply biosimilar products to these markets.
Due to the high cost to manufacture any biopharmaceutical product, coupled with the need to keep manufacturing costs low for biosimilars, it is not surprising that a significant number of respondents indicated that they “will not” or are “not likely” to manufacture their biosimilar in multiple locations. Yet, it is somewhat surprising that a quarter of the respondents indicated they are “somewhat likely” to manufacture in multiple locations.
It is clear from our bioPulse survey results that biosimilar developers are taking a variety of approaches and targeting various geographic markets to ensure supply of their products, employing a combination of in-house and outsourced manufacturing, in both established and growth markets. Once the biosimilar market is firmly established, likely within the next 5-7 years, we’ll see if this multimodal supply is still valid.
By Howard L. Levine (hlevinebptccom)
In recent years, dramatic improvements in product titer and yield in manufacturing operations, the development of more potent biopharmaceutical products such as antibody-drug conjugates, and the increased focus on developing products for personalized medicine of small niche markets have driven a demand for smaller, more flexible, and cost-effective manufacturing facility options. These trends, coupled with advancements in single use technologies have revolutionized biopharmaceutical manufacturing.
New facilities, such as the DSM Pharmaceutical Products “biologics plant of the future” in Brisbane, Australia and the Fujifilm Diosynth Biotechnologies new mammalian cell culture facility in Billingham, UK are being designed to utilize primarily single-use technologies for both upstream and downstream operations. These new flexible facilities enable not only the rapid production of clinical trial material but also offer the potential for more efficient commercial manufacturing of monoclonal antibodies and other biopharmaceutical products. To learn more about this exciting new trend in the biopharmaceutical industry, join me on November 19, 2013 for a Business Review webinar entitled “Going beyond flexible single use facility for achieving efficient commercial manufacturing.”
The Institute for Immunology and Informatics at the University of Rhode Island will be hosting its seventh annual Vaccine Renaissance Conference in Providence, Rhode Island on October 16-18, 2013. The Conference will be attended by Keith H. Wells, Ph.D., Senior Consultant and a recognized authority on the develoment of vaccines and medical countermeasures for biodefense and emerging diseases. Click here (kwellsbptccom) to schedule a meeting with Keith at the conference to learn how BPTC can support your vaccine development programs.
Join BPTC in Dublin, Ireland next week for Informa’s 11th annual BioProduction Conference to be held at the Doubletree by Hilton Hotel from October 22-23. We are thrilled to be exhibiting at this event (booth 13) and look forward to networking with new faces and reconnecting with old friends. Dr. Howard Levine, President and Principal Consultant, will be participating in the Breakout Session on the “Registration of new flexible facilities and ensuring replicability” on Wednesday morning at 9:40AM as part of the Flexibile Facilities track. We hope you will stop by the booth and check out our new website tool for the opportunity to receive credit for an hour of free consulting! If you are interesting in pre-arranging a meeting with one of our subject matter experts at the conference, please click here (jadambptccom) .