Generic Medicines and R&D: How Teva Produces and Delivers the World’s Largest Medicine Cabinet
Generic medicines are an essential part of modern healthcare. We explain why and look at the research, development processes and challenges involved in creating them.
Most of us will probably take some form of generic medicine [1] in our lifetime. In 2021, global sales from prescribed generic drugs were worth US $82 billion [2]. By 2026, the market is forecast to be worth $99 billion [3]. But what are they?
Generic medicines are created to be the same as branded drugs whose patents have expired. They must also pass stringent tests for safety, quality and efficacy. Generic medicines have the same active ingredients and produce the same clinical effects as branded drugs.
“People think that generics are different to branded drugs – they’re not, they’re the same,” explains Michael Banks, Senior VP Global Regulatory Affairs at Teva. “That’s why the approval process is so important, as the relevant agencies ascertain the medicines are equivalent to what’s already in the market.”
The biggest advantage of generic medicines is that they can be significantly less expensive to produce than branded medicines no longer protected by patent. That means that generic products can be developed at a lower cost and sold at a much lower price than branded products, enabling more people to have access to the medicines they need.
“Generics allow better access to healthcare globally. Generics are a necessary commodity for everybody.” says Michael Banks.
Generic medicines: increasing access for patients
Almost 200 million people around the world take a Teva medicine every day. In 2020, Teva medicines filled one of every 10 generic prescriptions in the United States, one of every five generic prescriptions in Canada, one of every eight in Germany, one of every five in the UK and one of every two in Chile.
At Teva, we are committed to ensuring access to healthcare, and that is why we focus a significant portion of our research and development budget on generics. In 2020, Teva invested nearly $1 billion in R&D activities and had more than 1,160 generic products in its development pipeline.
That investment benefits patients around the world, by providing access to affordable medicines.
Behind the scenes: what does it take to produce the world’s largest medicine cabinet?
From R&D to clinical studies, from manufacture to approval and market supply, every day 40,000 Teva employees around the globe are helping to get essential medicines to the people who need them.
People generally think of R&D only when they think of specialty drugs, the work that goes into researching and preparing new compounds. But there is a vast amount of R&D required to produce generics.
Why?
Because producing a generic version of a drug so that it works in the same way – with the same strengths and dosage forms, and using similar active ingredients as branded medicines - is pretty difficult. It takes a lot of research, innovation and specialist knowledge to make generic medicines.
You could think of it like this: turning a branded drug into a generic is like getting a recipe for a dish you’ve never made before. Imagine you get the recipe, but you can't use the same ingredients, and you need to produce exactly the same taste, size, texture and calories in the recipe. How do you do it? That's what our generics R&D team discovers.
Teva’s R&D uses a “Quality by Design” principle in the design, development and manufacturing of its products. This is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in their design, development and manufacturing. [4]
“Quality by design ensures that every one of those 200 million patients receiving our generics medicines receives a good product,” says Parag Shah, Senior Director and Site Head at Teva Pharmaceuticals.
“In our R&D center we are working on about 40 to 50 pipeline products at any one time. All are in different stages – from evaluation to mid stage to near completion. Our R&D program is driven by quality and safety, ensuring that every commercial product is consistent.”
Teva’s R&D team develops quality generic products that behave the same as the branded drugs in the market. Parag adds. “Our team has a responsibility to develop a product which is as good as the branded product or in some cases even better.”
Strict quality control is essential
Teva does this R&D by thorough tests, including dosage performance compared to the equivalent branded medicine and “in vivo” tests, comparing its overall performance to the branded drug. “In vivo” tests are performed on whole living organisms, such as humans, plants or cells.
Rigorous “stability” tests during the R&D phase ensure that the medicine is robust and will perform consistently throughout its lifetime.
Another essential hurdle for a generic medicine to clear is demonstrating “bioequivalence” with a branded drug. Bioequivalence is a measure of factors including how closely two drugs with the same active ingredients produce the same clinical outcomes and whether the branded and generic medicine are absorbed by the patient’s body at a similar rate.
Beth Rody is Senior Director, Generic Clinical R&D at Teva Pharmaceuticals. Her team supports most of the development sites at Teva. “We're responsible for running the bioequivalence studies that are needed to support approval of the generic product.”
Teva typically runs about 150 bioequivalence studies for global markets in a year, although the number was lower than usual in 2020 because of the Covid-19 pandemic, Beth adds.
How can Teva ensure that a generic medicine achieves bioequivalence to a branded one? Beth and her colleagues will review publicly available information about the branded product and also product specific guidance provided by the regulator. “We’ll research information on the pharmacokinetics of the drug product to design the study,” she says. Pharmacokinetics is the study of drug absorption, distribution, metabolism and excretion, which Beth’s team is responsible for, as well as making sure that the design of the bioequivalence study is appropriate...
Teva is committed to creating quality, affordable medicines for more people in more places around the world. Our scientists are developing generic medicines that aim to increase access to treatments that can improve patients’ health and save healthcare providers billions. Teva continues to strive for a healthier world.
[1] ‘Generic drug facts’, U.S. Food and Drink Administration, https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
[2] ‘Worldwide generic prescription drug sales from 2012 to 2026’, Statista research, https://www.statista.com/statistics/309411/global-total-generic-prescription-drug-revenue/
[3] ‘Worldwide generic prescription drug sales from 2012 to 2026’, Statista research, https://www.statista.com/statistics/309411/global-total-generic-prescription-drug-revenue/
[4] European Medicines Agency, https://www.ema.europa.eu/en/human-regulatory/research-development/quality-design
Read more
- Generic medicines, the what, why and who – watch the full story here
- Discover how Teva products help 200 million patients every day
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