Biosimilars are “highly similar–but more affordable–successors to biological drugs whose patents have expired.” Over the past two years, the biosimilars market has undergone instrumental. Biosimilars are finallyentering the US market and have the potential to be as disruptive as generic drugs after the Hatch-Waxman Act was passed in 1984.
Right now, the scientific and regulatory challenges that go along with getting biosimilars to market are being intensely discussed in the United States. However, no one has shed much light on what it takes to build a biopharma team to take on biosimilars. We’ll explore the shifting landscape of biopharma, the growing demand for low cost alternatives, and how the demands for talent are changing when it comes to BioPharma R&D.
The Growing Demand for Alternatives to Biologics
There is now a growing need to find cost-effective alternatives to expensive biologics, an industry that has grown to be worth US $138 Billion since the 1980s.
Currently, [expensive biologics] account for 16% of global pharmaceutical expenditure.
With the upcoming expiration of numerous major pharmaceutical patents, including names like Enbrel® and Remicade®, there are going to be huge opportunities for biosimilars to enter the market. This is especially true for areas like cancer and diabetes, according to a report by the Wienber Group
The United States is the BIG Opportunity for Biosimilars
For BioPharma leaders and executives, 2017 could be a pivotal year when it comes to biosimilars in the US. Last September’s US launch of Zarxio®, a copycat version of Amgen’s Neupogen®, was considered to be a breakthrough in a market that is nearly a decade behind Europe when it comes to biosimilars, according to a recent article by BioPharma.com.
Throughout 2016 there has been a trend towards increased biosimilar clinical trials along with an increase in the number of biosimilars applications filed with the FDA. While Hax-Watchman laid the foundation for biosimilars, the Affordable Care Act provided an opportunity for the introduction of biosimilars in the US through the implementation of the Biologics Price Competition and Innovation act. Despite this, the future of biosimilars in the US remains unclear, as Zarxio is currently the only biosimilar that is actually offered to the general public. When Zarxio® was introduced into the European market in 2009, it became the first biosimilar to gain a bigger market share than a reference product. Today, there are more than 100,000 patients prescribed the drug around the world.
Building the Biotech and Biopharma Workforce of Tomorrow
Companies looking to push into the biosimilars space and be successful doing it will need the right people in place. Many large pharmaceutical companies are shifting their presence to biopharma, including Bayer, Novartis and Bristol-Meyers Squibb. When it comes to this industry, your staff can be the difference between maintaining the status quo and a making a breakthrough.
Biopharma companies are addressing the current talent gap in the scientific workforce by looking for fresh skills and alternate approaches to R&D staffing. Additionally, new R&D organizational models are changing talent demand and creating new challenges. According to a recent study the Health Research Institute, over half of industry executives report that hiring has become increasingly difficult and less than a third feel confident they will have access to top talent. For companies looking to be the next breakthrough name, this presents a challenge.
Attracting and Retaining Top Biopharma Talent
Biopharmaceutical companies must create a workplace where innovation can thrive. “Scientists are driven by the chance to tackle tough problems, but not when they are operating in a pressure cooker environment with incentives that aren’t well aligned with company goals or their own sense of satisfaction,” said Michael Mentesana, U.S. pharmaceuticals and life sciences R&D Advisory services leader at PwC in a recent press release. “Real R&D transformation will not be complete until the R&D culture itself is rebooted and unless HR, R&D and senior management work together from the beginning.”
Many companies are seeking alliances and partnerships outside of their own walls. According to the PwC press release, “the two most common outside partnerships biopharmaceutical companies have been pursuing are with academic medical centers and third parties such as contract research organizations, according to HRI.”
A New Set Of Skills is Needed in BioPharma
In today’s new R&D environment, top companies are looking for a new set of skills, with one of the leading skills being the ability to develop and manage outside partnerships. Additionally, candidates will need sharp skills in regulatory science and should have a deep understanding of new rules and regulations. There will also be a greater demand for those that specialize in Bioinformatics and health economics outcome research as data begins to play a bigger role in researching and proving that products actually do improve health or reduce overall healthcare costs.
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