Keeping Costs Down: A Quality Strategy Can Help Life Sciences Firms Remain Competitive
Most famous for its juggernaut cell phone business, Samsung entered the life sciences arena in 2011 with the intention to become an expert in manufacturing biologics. The actions it’s taken in the time since definitely support that proclamation. From investing $2 billion to building multiple production plants, it is now the largest for-hire biologics manufacturer in the world.1
In addition to its contract manufacturing plans, Samsung has a division devoted to making its own biosimilars of biologics whose exclusivity periods are expired or close to expiring. This aim, in itself, would not be especially noteworthy. Other companies have adopted the same strategy. What’s particularly striking about Samsung’s biosimilar initiative is the company’s claims that it can manufacture the copycat drugs at half the cost of Western drug-makers. A stunning declaration to make in a time when many people remain uncertain about the quality, safety, and efficacy of biosimilar products despite the purported cost savings due to increased competition.
Samsung shows no signs of faltering, either. In fact, the company appears to be gaining momentum. It recently won regulatory approval to market its Enbrel biosimilar in Europe.2 While the company has no plans to market the rheumatoid drug copycat in the United States as of yet, it has sought market approval in Canada. And despite the fact that Amgen, who markets the biopharmaceutical in Canada, has filed a lawsuit against Samsung for supposedly violating its patents, many experts view the legal action as merely a delaying tactic.3
Other companies who develop biosimilars will surely be inspired by Samsung’s example. The situation facing Amgen in Canada may, in fact, become an all-too-familiar scenario. But are such lawsuits the only strategy life sciences firms have at their disposal? A successful suit may stave off the encroachment of competing biosimilars, but the increasing number of copycat approvals suggest that they’re only putting off the inevitable. After all, unless efforts are made to extend market exclusivity—whether by new formulations or improved second generation products—their advantage ultimately has a time limit.
A Quality Strategy Can Boost Efforts to Compete against Makers of Cheaper Alternatives
The increased pressure from other companies leaves life science firms with no choice but to find ways to cut costs and streamline their R&D workflow. One area they can examine for areas of potential improvement is their organizational quality strategy. Traditionally, quality processes are a large source of bottlenecks during the release cycle due to outdated systems and disparate applications. In a time when many biologics are approaching the end of their exclusivity term, time has become of the essence. The cause of any potential delays must be isolated and minimized as much as possible. Otherwise, companies will lose their advantage to ambitious competitors.
As previously mentioned, doubts still linger in the public’s mind over biosimilars—especially in the U.S. where the FDA has yet to clarify its standards for the copycat drugs despite the approval of Zarxio last year. Even though the government agency has intentions to establish clear guidelines in the near future, there’s no definite timeline as to when that’ll actually happen. In the meantime, life sciences companies can exploit the uncertainty by adopting quality strategy solutions that support the manufacture of high-quality biotherapeutic products. In the end, patients prefer safe and effective therapies of high quality versus cheaper alternatives with unknown potential side effects—especially in the realm of biologics, whose mechanistic actions are far more complicated than their small-molecule drug counterparts.
Another advantage of streamlined quality strategy solutions is that they function on a closed loop. Flagged items and notifications later in the workflow serve as feedback regarding quality in earlier steps. Individuals involved in the affected stages can then work to adjust their protocols to boost quality, thereby leading to a cycle of constant product improvement. By looking for areas that can be refined, companies potentially have the option of releasing second generation products with superior performance over the original. In addition to enhanced formulations, companies can develop better administration techniques or more effective dosing schedules. For example, oral administration will win favor with patients due to its convenience over traditional intravenous infusion methods. Depending on the circumstances, firms might even be able to seek an exclusivity extension. Look to the example of Enbrel in the United States. Its exclusivity term isn’t set to expire until 2028. No doubt that plays a role in Samsung’s decision not to pursue U.S. approval for their biosimilar at this time.
BIOVIA Total Quality is a comprehensive solution geared toward supporting the efforts of life sciences organizations to streamline their quality strategy processes. By integrating organizational quality procedures into one harmonized system, it minimizes bottlenecks through standardization and automation. Through the reduction of compliance risks and boosting of overall efficiency, an organization can focus its efforts on product quality and improvement instead of non-value-added tasks. If your organization is interested in adopting an effective quality strategy to remain competitive in an increasingly crowded market, then it will need the best tools to make those aims a reality. Please contact us to learn more about BIOVIA Total Quality today.
- “UPDATED: Samsung ponies up $740M to create massive biologics production site in South Korea,” November 30, 2015, http://www.fiercepharma.com/story/samsung-ponies-740-million-create-massive-biologics-production-site-south-k/2015-11-30 ↩
- “Samsung Gets European Approval for Enbrel Copy,” January 18, 2016, http://www.wsj.com/articles/samsung-gets-european-approval-for-enbrel-copy-1452996002 ↩
- “Newsmaker Samsung Bioepis faces patent suit by Amgen,” January 13, 2016, http://www.koreaherald.com/view.php?ud=20160111001129 ↩