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Generic medicines are an essential part of modern healthcare. We explain why and look at the research, development processes and logistical challenges involved in creating them.
Most of us will probably take some form of generic medicine 01 in our lifetime. In 2021, global sales from prescribed generic drugs were worth US $82 billion 02. By 2026, the market is forecast to be worth $99 billion 03
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 have the same clinical effects as branded drugs. They are also as safe to use.
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. In allowing equivalent products to enter the market, you have more competition and that can change the price significantly.
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.
Almost 200 million people around the world take a Teva product every day, making Teva’s medicine cabinet the biggest in the world. Teva produces over 3,500 products including many of those listed by the World Health Organization (WHO) as the medications considered to be most effective and safe to meet the most important needs in a health system.
Find out more about Teva medicines on the WHO’s Essential Medicine List.
It’s an unfortunate fact that global inequalities mean not everyone has access to quality medicines - medicines that manage disease, fight infection, or simply improve overall health. Teva believes everybody should and so it focuses a significant portion of its 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.
Teva also mobilized quickly during the COVID-19 crisis, maintaining a largely uninterrupted supply chain with enough stock to meet demand around the world.
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.
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.
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.
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. “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.”
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. 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. “My team is responsible for that and making sure that the design of the bioequivalence study is appropriate.”
In a big pharmaceutical company, one of the organizational challenges is handling R&D for scores of generic medicines at different stages of development.
“In our R&D center we are working on about 40 to 50 pipeline products at any one time,” Parag says. “All are in different stages – from evaluation to mid stage to near completion.”
The financial benefits for healthcare systems and patients by having lower cost options for medications available from Teva’s R&D are impressive.
Teva has one of the largest pharmaceutical supply chains in the world, delivering medicines to where they’re needed, with the ongoing aim of increasing access to essential medicines, so more people and more healthcare systems can receive quality care. Generic medicines are a crucial part of this mission.
Here are 22 quick facts about generic medicines
A generic medicine is a medicine that is an equivalent substitute to a brand name drug. Generic medicines contain the same active ingredients as the original brand products, and are available in the same strengths and dosage forms as the originals. A generic drug must work the same way in your body and produce the same treatment result as the brand name drug.
Sometimes the generic version of a drug may have a different color or shape from its innovative original, but these changes do not affect the drug's attributes. That’s because the appearance of a brand-name drug may be trademarked by the original manufacturer, so the generic product might be required to be a different shape or color. But, the active or key ingredients must be the same.
All brand-name drugs have a generic name. The generic name often appears next to the brand name and is the active ingredient(s) in the medication. Regulators often require that generic drugs are given a different name than the brand-name drugs, in order to avoid confusion. Typically, the generic name of a medicine is based on the name of its active ingredient(s), whereas the names given to brand-name drugs are intended for marketing purposes. There are a few unique cases where the generic medicine may also have another name besides the active ingredient. Ask your pharmacist if you have any questions.
Generic drug facts’, U.S. Food and Drink Administration, https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Worldwide generic prescription drug sales from 2012 to 2026’, Statista research, https://www.statista.com/statistics/309411/global-total-generic-prescription-drug-revenue/
Worldwide generic prescription drug sales from 2012 to 2026’, Statista research, https://www.statista.com/statistics/309411/global-total-generic-prescription-drug-revenue/
