Coherus BioSciences, one of our founding member companies, is a commercial-stage biopharmaceutical company focused on the research, development, and commercialization of innovative immunotherapies and biosimilars to treat cancer. Coherus started with a vision – to provide the highest quality biosimilar treatments to patients, to expand access to important, cost-effective medicines, and to deliver significant savings to the U.S. healthcare system. Since launch in 2010, Coherus has saved the United States healthcare system over $2 billion in savings, with $1.5 billion annual savings to the market overall.
David Sanders, Vice President of Government Affairs & Policy, gave us insight into the founding of Coherus, the importance of preferring American made in the federal political landscape, and what can be done going forward to encourage these policies.
When did Coherus’ commitment to American made start?
It really started from our founding. Coherus is an American company created out of U.S. federal legislation in 2010, called the Biologics Price Competition and Innovation Act (BPCIA). This was an amendment to the Patient Protection and Affordable Care Act (PPACA) which I was fortunate enough to help contribute to as a lobbyist for Teva USA.
Our founder and CEO, Denny Lanfear, was committed from the very beginning to building a company that brought value back to the system by creating competition for drugs in the biological space. He’s an expert engineer, and he decided to get together with a group of friends so that he could create a biosimilar company to deliver value back to the patient, to the system, and to Medicare itself. He decided that when the PPACA and BPCIA passed into law that he would create this company to do just that. So, he built the company in California to be an American made biotech.
What are the challenges to remaining an American made company as Coherus expands? Why does that commitment to American made stay?
By and large, pharmaceutical manufacturing for the last 30 years has been moving abroad because of labor cost, flexibility, and tax incentives.
The challenge for many companies is that it costs less to produce drugs abroad, whether it is in Eastern Europe, Asia or India. So our challenge is making the decision to continue to work with American made manufacturing partners. Coherus has a partnership with KBI Biopharmaceuticals in Boulder, Colorado, in a facility that we helped turn around to create a production facility that produces our cancer support drug, UDENYCA.
We are continuing to invest in that partnership with KBI. Additionally, the challenge is that the American tax system and the American government do not really recognize or reward American made
pharmaceuticals over foreign counterparts. So we think that is wrong, and something must be done about it. How can we create highly skilled, well-paid, taxpaying jobs here without recognizing the quality and reliability of U.S. made pharmaceuticals? Don’t we do this for other industries such as semiconductors?
What does the competition with other biotechnology companies in the U.S. look like? How does this affect your commitment to American made?
In fact, the government is required to contract a set amount with American made products. But the problem has been that the federal government has waived that requirement. They have looked the other way. That is a problem, because we believe that U.S. made and U.S. -ally made products are of high quality, because we know they are tested and inspected by the FDA. So the surety of supply for the complex biologic or biosimilar should be a quality metric when it comes to the government and government contracting.
We need to recognize that contracting with American made products is not only in the law, but it needs to be enforced- and even expanded. It should be enforced in our treatment and patient areas because we are supporting more than 700 jobs in America.
What benefits has Coherus found in being a part of Securing America’s Medicines and Supply (SAMS)? Why did you join and what are some hopes for the future?
We helped create SAMS to provide an entity for consensus building in order to increase the production of American made medical products. We were thrilled to partner with Teva Pharmaceuticals originally, followed by AmerisourceBergen, and other companies such as Amneal Pharmaceuticals, iRemedy, fluidIQ, and US Biologic. We are happy to partner with them on policy, public affairs, and general partnership to try to strengthen law pertaining to American pharmaceuticals and American medical products – whether it is tax law, like the Made in America Act, which we fully support, or supply chain provisions such as the Strategic National Stockpile (SNS) flexibility laws. These policy changes in particular would allow companies like AmerisourceBergen to store and to keep critical drugs at their facilities so that the American system can respond quickly in a time of need.
What is the importance of Coherus’ products being American made? What makes these products essential?
We produce biosimilars and are now expanding into branded drugs within the immuno-oncology space. Our biosimilars create value by expanding access to critically needed medicines, but also by bringing savings to the U.S. federal government and other health care payers. Our immuno-oncology portfolio is focused on developing novel drugs to address unmet needs for cancer patients. And that is part of the
reason why we have so much energy in the space – because there is not a mechanism currently that exists to recognize and reward the savings of that expanded access. We serve tens of thousands of patients right now with UDENYCA. We are also launching at least three more biosimilars in the coming years. We need to work in partnership with the government to encourage the continued adoption of biosimilars so that the patients and payers, including the government and commercial insurers, can realize the benefits of expanded access and savings.
We are at an age where one of the biggest complaints of the health care system is cost, or the high cost of pharmaceutical products and of medical care. We are an actual business that brings a solution to that problem. Expanding access and delivering savings is a virtuous cycle that can save lives and deliver benefits for patients, the government, and the healthcare system generally.
As Coherus is growing, are you planning on expanding your manufacturing base in the U.S.?
We are planning for the potential launch of as many as four new products in 2022 and 2023. We want to be able to manufacture as many of our products as possible here to de-risk the future supply chain concerns for these critical drugs.
We are interested in exploring partnerships with the government so that we can build on our existing partnerships with KBI, Emergent BioSolutions, and other manufacturing partners in the United States. We fully support funded mechanisms for BARDA and ASPR because expansion of the industrial base supply is a key priority. They understand the challenge and the opportunity. Second, we support BARDA, because we support the development of new therapies, vaccines, and medical countermeasures.
SAMS is working hard to support these policy goals, and Coherus supports them as well. Good policy makes for new American jobs, and new American tools to fight cancer, COVID and other diseases.
What we have learned in the last two months alone from the war in Ukraine is that too many American products are reliant on either Eastern Europe, Asia, or elsewhere. This cannot continue to be the case. We must turn that ship of off-shoring around. One way to do it is to recognize our great partners at SAMS, from AmerisourceBergen, to iRemedy, to Amneal, to Teva Pharmaceuticals and others. We need to build up more American manufacturing.