At STAT’s 2026 Breakthrough Summit East, Amneal’s Chirag Patel highlighted vulnerabilities in the U.S. antibiotic supply chain and warned that limited domestic production poses risks to national health security. He also pointed to slow biosimilar adoption as a key barrier to expanding access and reducing costs, calling for greater coordination across policy, payers, and industry.
The following transcript has been lightly edited for content and clarity.
Chirag Patel: Good afternoon. My name is Chirag Patel, co-founder and Co-CEO of Amneal Pharmaceuticals. We’re a leading affordable medicines company in the United States. We fill about 175 million prescriptions per year — about one out of five — and still make half of our products in the United States.
And how do we define affordable medicines? Three categories. One is generics, which are, as you know, a huge success story. Over the last 20 years, our industry has saved $4.5 trillion, $430 billion just last year. It’s a huge success story.
And I’m going to cover two topics today. So we have achieved affordability in generics, then hospital injectables. And then we have biosimilars, which is a huge opportunity, mainly for the patient to get more access to the medicine.
Let’s talk about essential medicines. As you know, in America, we led antibiotics production since the 1940s, 50s, 60s, 70s, 80s. In 1990, last 30 years, all the productions have moved out. So today we have 1% of fermentation capacity in the United States. 1%, only 1%.
Fermentation is required to make key starting material.
You make key starting material, then you make the intermediates — the 6-APA, 7-ACA — that make all the penicillins and cephalosporins. As a country, we make near nothing in the U.S.
“I understand cost plays a key role, but as our country, we cannot afford to not have antibiotics fermentation capacity in the United States. It creates uncertainty in national health security.”
80% is coming from China.
And yes, antibiotic supply is available today, everything works normally, but what if it isn’t? A public-private partnership would be required to help antibiotics capabilities back to the U.S.
Also, we’re working on a legislative front for CMS to require — just like controlled substances — that you must buy U.S.-made antibiotics for the plans, which would then create a nice 50% market formation in the United States, from key antibiotic starting material, intermediates, active pharmaceutical ingredient (API), and finish dose.
We would, as a nation, breathe really well knowing that we have the domestic antibiotics capacity. And we are keeping the global capacity intact as well. It’s a global supply chain resiliency. We’re working on it.
And the second topic is biosimilars. So the generics have been a huge success. 90% of all generics, when we launch, 90% adoption on average. And cost is so affordable: $5 copay, $10 copay, and 90% of prescriptions are filled using generics drugs. We have done a great job as industry.
Biosimilars, that’s not the story yet. We have to work together as industry with payers, providers, the manufacturers. And I want to thank the FDA for streamlining the processes. Now, the entire regulatory process, which used to take seven years, now it’s four to five years, used to cost $150 to $200 million each product. Now it’s $50 to $70 million. So you’ll see more manufacturers that will be entering.
The problem is you saw what happened with Humira. Now there are 118 biosimilar candidates. Only 10% are actively being worked on because biosimilars are treated as quasi-brand. You need to get coverage. We do not need to get any insurance coverage for generics products. We do not need to wait on the generic side to get the reimbursement code for six to nine months — it’s immediately given and insurance covers it.
Biosimilars should be covered as a preferred formulary on the insurance, just like generics. Then you’ll see the adoption right away. Everybody’s working on it. I’m very hopeful that sanity will prevail over two, three years.
It’s been 12 years of biosimilars since Congress passed the legislation. Even if you recall, the generics drugs took almost 15 years before the adoption was almost to 70, 80 to 90%. You’ll see that in biosimilars.
But we need all the industry players on board. And it’ll create a tremendous access. And savings — we would have another $100 billion or $150 billion a year savings.
But more importantly, did you know that 50% of cancer patients declare personal bankruptcies* and they don’t finish their treatment? Many of their immunology drugs are biologics — and more and more biologics will be there and peptides will be there.
I urge that we work together to have CMS issue the reimbursement code immediately. We don’t need to pay insurance companies rebates for biosimilars — that’s not the purpose of biosimilars. Just like we don’t pay any rebates for generics. And we need their adoption by the providers immediately as well.
Thank you very much.
*Editor’s note: In population-based studies, about 1.7% of cancer patients file for bankruptcy within five years of diagnosis, though financial hardship is more common.
