Mario DiPaola, Senior Scientific Director, Charles River Laboratories07.03.17
With the acceleration in the development of biosimilars, we are starting to see an imbalance in the industry. This will manifest in several ways, including financial, market competition, innovation and geographic redistribution. As a result, the biologics industry is due for substantial changes.
In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was passed as part of the Affordable Care Act (ACA). The FDA has since issued several guidance documents, paving the way for regulatory approval of biosimilars in the United States. As listed in Table 1, four biosimilars have been approved.
Table 1: Currently approved biosimilars within the US
Additionally, there are currently six 351(k) applications under FDA review, and at least 14 biosimilars in Phase III trials. The pipeline is substantial.
In short, the biologics market has emerged as one of the hottest segments of the pharmaceutical industry, and is expected to reach US$390 billion by 2020, with biosimilars accounting for at least 10% of the overall biologics market. The number of biosimilars in various stages of development is staggering, as the table below shows.
Table 2: Biosimilars in development1
It’s clear that over the long run, the advent of biosimilars will be beneficial to the industry. It will increase competition and encourage more innovation. It will also be good for patients. The increase in competition, along with a decrease in the price of these life-saving drugs, will make biosimilars more affordable and accessible to a large proportion of the population. Ultimately, this will result in an overall expansion of revenue for the biopharmaceutical sector.
But for the short term, at least, the emergence of biosimilars could also adversely impact some of the industry’s leading drug makers, which stand to lose market share on their current portfolio of biologics.
Development and manufacturing, product analysis, and global markets are just a few of the areas that will be impacted significantly by the growth of the biosimilars market. Here’s how.
Development and Manufacturing
The companies most affected by the introduction of biosimilars will likely be forced to expand their pipelines with novel products to shore-up their revenues. Similarly, companies currently engaged in biosimilar development will likely see their sales increase and, as they gain sufficient experience and know-how, will venture into the development of novel biological products.
As the field becomes more competitive, there will be a strong push for innovation and increased efficiency in the development process. Toward this end, we will see substantial improvements and efficiency gains in biosimilar manufacturing, including:
· multi-product facilities
· clinical/commercial scale single-use systems
· continuous processing
· improved expression systems, along with other genetic engineering advances
· automation, monitoring, and improved process control
· modular facilities that can be repurposed on demand
Product Analysis
Biosimilar products will also benefit from improved analytical techniques. A decade or two ago, these were limited or nonexistent but today, with tools like high resolution mass spectrometry (HR-MS), we can detect minor protein modification, which in turn affords improved product characterization and quality control.
These advances mean that we will have a much better understanding of biosimilar products than we did of originator products when they were being developed and undergoing regulatory review, and the more we learn about the structural features, not only the primary structure but also higher order structures, the greater chance of creating safer biosimilars.
As more companies and more products enter the biosimilar space, it is anticipated that there will be more outsourcing of analytical and manufacturing needs, and an increased demand for better analytical technologies that can provide faster and more accurate analytical data.
Global Markets
While Europe and the US have been the primary focus, biosimilars will also have a significant impact in Asia, primarily in India and China. Both countries have large populations and strong purchasing power, making them prime markets for biosimilar manufacturers. These markets will be served partially by local biopharmaceutical companies, propelling growth of the Chinese and Indian biopharmaceutical sectors.
An influx of biosimilars into the biopharmaceutical market is long overdue; it is true that some major pharmaceutical and biopharmaceutical companies may be adversely affected over the short term. But overall, the growth of biosimilars will lower the cost of these important therapeutic products for patients, and result in increased efficiency in both production and testing, ultimately leading to more innovative technologies and therapies.
References: 1Biosimilarpipeline.com
Mario DiPaola is a Senior Scientific Director at Charles River Laboratories in Woburn, MA and specializes in safety assessment and biologics.
In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was passed as part of the Affordable Care Act (ACA). The FDA has since issued several guidance documents, paving the way for regulatory approval of biosimilars in the United States. As listed in Table 1, four biosimilars have been approved.
Table 1: Currently approved biosimilars within the US
Drug | Sponsor | Status |
Zarxio (filgrastin-SNDZ) | Sandoz | Launched |
Inflectra (infliximab-DYYB) | Celltrion/pfizer | Launched |
Amjevita (adalimumab-ATTO) | Amgen | Approved; launch planned for 2018 |
Erelzi (etanercept-SZZS) | Sandoz | Approved; launch planned for 2018 |
Additionally, there are currently six 351(k) applications under FDA review, and at least 14 biosimilars in Phase III trials. The pipeline is substantial.
In short, the biologics market has emerged as one of the hottest segments of the pharmaceutical industry, and is expected to reach US$390 billion by 2020, with biosimilars accounting for at least 10% of the overall biologics market. The number of biosimilars in various stages of development is staggering, as the table below shows.
Table 2: Biosimilars in development1
Drug | Biosimilars in development |
Epoetin alfa | 81 |
Interferon- alpha | 63 |
Insulin and analogs | 61 |
Neupogen (filgrastin) | 58 |
Rituxan (rituximab) | 54 |
Herceptin (trastuzumab) | 38 |
Somatotropins | 35 |
Avastin (bevacizumab) | 33 |
Enbrel (etanercept) | 31 |
Interferon-beta | 29 |
Neulasta (pegfilgrastin) | 28 |
Remicade (infliximab) | 17 |
Lantus (insulin glargine) | 13 |
It’s clear that over the long run, the advent of biosimilars will be beneficial to the industry. It will increase competition and encourage more innovation. It will also be good for patients. The increase in competition, along with a decrease in the price of these life-saving drugs, will make biosimilars more affordable and accessible to a large proportion of the population. Ultimately, this will result in an overall expansion of revenue for the biopharmaceutical sector.
But for the short term, at least, the emergence of biosimilars could also adversely impact some of the industry’s leading drug makers, which stand to lose market share on their current portfolio of biologics.
Development and manufacturing, product analysis, and global markets are just a few of the areas that will be impacted significantly by the growth of the biosimilars market. Here’s how.
Development and Manufacturing
The companies most affected by the introduction of biosimilars will likely be forced to expand their pipelines with novel products to shore-up their revenues. Similarly, companies currently engaged in biosimilar development will likely see their sales increase and, as they gain sufficient experience and know-how, will venture into the development of novel biological products.
As the field becomes more competitive, there will be a strong push for innovation and increased efficiency in the development process. Toward this end, we will see substantial improvements and efficiency gains in biosimilar manufacturing, including:
· multi-product facilities
· clinical/commercial scale single-use systems
· continuous processing
· improved expression systems, along with other genetic engineering advances
· automation, monitoring, and improved process control
· modular facilities that can be repurposed on demand
Product Analysis
Biosimilar products will also benefit from improved analytical techniques. A decade or two ago, these were limited or nonexistent but today, with tools like high resolution mass spectrometry (HR-MS), we can detect minor protein modification, which in turn affords improved product characterization and quality control.
These advances mean that we will have a much better understanding of biosimilar products than we did of originator products when they were being developed and undergoing regulatory review, and the more we learn about the structural features, not only the primary structure but also higher order structures, the greater chance of creating safer biosimilars.
As more companies and more products enter the biosimilar space, it is anticipated that there will be more outsourcing of analytical and manufacturing needs, and an increased demand for better analytical technologies that can provide faster and more accurate analytical data.
Global Markets
While Europe and the US have been the primary focus, biosimilars will also have a significant impact in Asia, primarily in India and China. Both countries have large populations and strong purchasing power, making them prime markets for biosimilar manufacturers. These markets will be served partially by local biopharmaceutical companies, propelling growth of the Chinese and Indian biopharmaceutical sectors.
An influx of biosimilars into the biopharmaceutical market is long overdue; it is true that some major pharmaceutical and biopharmaceutical companies may be adversely affected over the short term. But overall, the growth of biosimilars will lower the cost of these important therapeutic products for patients, and result in increased efficiency in both production and testing, ultimately leading to more innovative technologies and therapies.
References: 1Biosimilarpipeline.com
Mario DiPaola is a Senior Scientific Director at Charles River Laboratories in Woburn, MA and specializes in safety assessment and biologics.