Firms Can Develop Next Generation Biologics to Compete with Biosimilars
As more biologics reach the end of their patent protection periods, how can companies compete with biosimilars? Image source: Flickr CC user Jamie
With billions of dollars at stake, debate continues to rage over the impact of biosimilars upon the pharmaceutical market. With only two biosimilar drugs having received FDA approval, speculation about their ability to affect the sales of biologics remains unclear. To make market predictions even more difficult, a recent federal circuit court ruling further delays the launch of new biosimilars in the U.S. by requiring companies to give makers of source biologics six months’ notice.1 These setbacks haven’t deterred biosimilar manufacturers, though. More of the copycat drugs are entering clinical trials, increasing the likelihood of market approvals—especially as FDA guidelines for determining reference biologic and biosimilar interchangeability become solidified. Estimates now claim that biosimilars could capture at least 30% of the market.2
This potential loss of market share (along with pressure from legislators and taxpayers hoping that biosimilars will force companies to decrease biologic drug prices to remain competitive3 ) is fueling anxiety among biotherapeutic developers, but companies still have options at their disposal. Manufacturers can take a proactive approach by developing innovative, next generation drugs that allow them to compete both with biologics and the biosimilars based on them.
Life Science Organizations Can Find New Ways to Compete with Biosimilars
Many older biologic drugs are approaching the end of their market protection. In fact, one of the most popular biotherapeutics—a drug that treats autoimmune diseases—will be seeing its composition-of-matter patent expire by the end of this year. At that point, patent-infringement litigation will no longer apply. And when over half of a firm’s sales depend on one biologic drug, lifting patent protections can cut deeply into market share.
With at least one biosimilar waiting in the wings to capitalize on this key expiration, you can be certain that many companies will be watching the effects in 2017. Several key questions about exact impact and loss of profit will finally be answered. Until then, how can biotherapeutics compete with lower-cost biosimilars? One way would be to improve life science innovation, which may be even more effective at retaining market share than litigation efforts.
Biologic Companies Can Improve Upon Existing Drugs to Compete with Biosimilars
Earlier this year, a rival biologic company began the process of seeking FDA approval of their own autoimmune disease drug. If received, they could launch as early as next January. The outlook remains positive as this rival biologic’s clinical trial data supports better efficacy than the drug currently available on the market. Not only does it improve upon its predecessor’s performance in many ways—such as superior treatment in early stages of rheumatoid arthritis—the new drug also alleviates symptoms in patients who don’t respond to current forms of treatment at all. Targeting patients who are unresponsive to common treatments is a strategy already used by companies developing therapies for certain cancers, so applying a similar strategy with this new drug implies that it can be utilized across all disease and condition types.
Improving upon competitor biologic drugs has a few advantages. If these next generation therapeutics gain market approval, they will be at the beginning of their protection period, which will insulate them from immediate biosimilar encroachment. In addition, biosimilars waiting to come onto the market will be based on older drugs. If a next generation drug demonstrates better clinical efficacy, physicians are likely to prescribe it. The availability of a biosimilar may ultimately have no impact since its formulation will have been based upon the older, lesser-performing reference biologic.
Drug discovery for underserved patient populations can be one strategy used to compete with biosimilars. Doing so will require that organizations manage existing information and experimental results to find areas that would benefit from such an approach. Of particular importance will be accessing the sequence and assay data necessary for biologic development. Biologic R&D generates high volumes of data, making it difficult to glean useful insights. When going back to identify potential targets, the ability to assess information becomes even more important. Laboratories with data management systems equipped with the proper tools to aid analysis.
While biosimilars will most certainly have an impact upon the market, the extent to which they will affect costs and competition is still subject to debate. Nevertheless, companies can prepare to compete with biosimilars by adopting a simple, yet effective, strategy: innovation. By developing drugs that improve upon earlier iterations, companies can continue to protect their market advantage from lower-cost generic versions.
BIOVIA Biologics is an integrated suite of processes that support the discovery, development, and manufacturing of life-improving biotherapeutics. Its tools enable users to improve upon current drug performance by offering powerful data management systems that can process, analyze, and assess information. Easy access to biologic information supports scientists’ ability to glean crucial insights about drug potential, developability, and optimization, leading to the discovery of better, more effective mechanisms to treat patients. If you’re interested in learning how a digital solution can aid your efforts to remain competitive in a tight market, please contact us today.
- “Gormley’s Take: Road to Launching ‘Biosimilar’ Drugs Just Got Longer,” July 13, 2016, http://www.wsj.com/articles/gormleys-take-road-to-launching-biosimilar-drugs-just-got-longer-1468409401 ↩
- “Forget Biosimilars: It’s This Threat That Could Dent AbbVie’s Top Line,” January 31, 2016, http://www.fool.com/investing/general/2016/01/31/forget-biosimilars-its-this-threat-that-could-dent.aspx ↩
- “A new drug that could save the US billions just got one step closer to an approval,” July 12, 2016, http://www.businessinsider.com/fda-panel-recommends-humira-biosimilar-2016-7 ↩