Biosimilars – Understanding The Drug Market
Since the approval of the first ever biologic, insulin, in 19821, biologics have become a key part of healthcare. Biologics encompass an entire class of drugs derived from, or containing parts of, living organisms, including vaccines, gene therapies and recombinant proteins2, and they combat a range of diseases3.
Once a biologic is approved in Europe, it has data exclusivity in the market for eight years to protect its intellectual interest. In the US, a reference biologic receives a 12-year market exclusivity instead4. Once this exclusivity period expires, the data is released so biosimilars can apply for approval, creating competitors in the market, which should result in a financial benefit to patients and reduce the financial burden on the healthcare system5.
A biosimilar is a product with very few differences to the original reference drug and where the manufacturers have shown that the newer biosimilar has similar safety and efficacy to the reference product6. A well-known example of an original (or ‘reference’) drug7 and its biosimilars is Humira (adalimumab)8. Humira was first approved by the FDA in 2002 for rheumatoid arthritis, followed by a number of other indications9. Humira was the market leading blockbuster drug for some of these diseases until the European launch of a biosimilar called Amjevita (adalimumab-atto) in 201810.
A major driving force behind biosimilar production has been the ability to produce biosimilars more cheaply than the reference drug, and introduce competition to the market11,12. The EMA approved the first biosimilar in 2006, in contrast to the FDA whose first biosimilar approval was only in 201913, but who now has an action plan to ramp up their approvals of biosimilars. The plan includes creating new tools to aid biosimilar development and their sponsors. The FDA also wants to explore data sharing of non-US licensed products from foreign regulators14. However, a recent science and policy report by HealthyWomen.org (Biosimilars & Women’s Health) suggests that not all biosimilars have a significantly cheaper price tag as their production costs are still high. With the addition of more and more competitors into the market this could all change15, in favour of patients.
What can Biosimilars do for Women’s Health?
Women’s health encompasses a vast range of diseases that do not just affect the reproductive system, but any disease that is more prevalent in women than in men. The global women’s health market size was $35 billion in 2019 and is expected to grow to $41 billion by 202716. However, in the next few years, patent/exclusivity expirations for many medicines including biologics across contraception, urinary incontinence, menopausal disorders and rheumatoid arthritis are expected to bring in more competition to the market and drive prices of some medication down17. The osteoporosis market has already seen its three biosimilars approved, Terrosa by Richter in 201918 Movymia by Thornton & Ross in 201919 and more recently in 2021, Livogiva by Theramex20, making this a promising avenue for biosimilar development, to support women suffering from this disease.
What is Osteoporosis?
Osteoporosis is a disease of the bones, where they weaken over several years. Bone loss is normal with ageing due to more resorption of bone than formation, but this disease results in rapid, abnormal bone loss. Causal factors are often thought to be a lack of vitamin D, hormonal diseases, and little exercise – but more recent evidence suggests links between osteoporosis and the immune system, gut or cell silencing21.
Osteoporosis affects 3 million people in the UK22. In the US, it is thought to affect more than 10 million adults, 80% of whom are women23. Bone loss occurs after menopause, and the risks are higher in women with early menopause, but this disease can affect men and children too24. Current treatments in the UK focus on calcium/vitamin D supplements, bisphosphonates to slow bone from breaking down in the body, selective oestrogen receptor modulators to maintain bone density, and testosterone in men when osteoporosis is caused by hormone deficiency. A biologic treatment available to some women is parathyroid hormone (PTH) such as teriparatide (drug name: Forsteo) which helps form more bone25.
In the UK, Forsteo is recommended for women who are over 65 with specific bone density scores or who cannot take bisphosphonates26. Forsteo is identical to the active fragment of human PTH, and stimulates osteoclast activity, which forms bone. It also increases calcium levels in the body by increasing absorption from food and reducing loss in urine. Randomised clinical trials highlighted that Forsteo reduced vertebral fractures, compared to placebo, and was more effective than alendronate (a bisphosphonate currently used as first-line treatment) at increasing bone density27.
The yearly cost of Forsteo in the UK is £3,544, which is high when compared to non-biologics, such as alendronate, which costs approximately £300 a year - depending on dose28. However, the approval of new biosimilars could create competition in the market and reduce the price tag of osteoporosis medication for patients in the future.
How can The MedComms Industry help The Biosimilars Market?
The HealthyWomen.org report highlights one of the barriers to the uptake of biosimilars lies in communications, or specifically, lack of patient awareness and clinician knowledge of biosimilars. Patients have safety concerns and do not always understand the similarity between a reference drug and its biosimilar29.
This is where TVF Communications can help! Our vast experience in patient campaigns and medical education, places us as an ideal partner to help pharmaceutical companies reach their audience at the right time, in the right way. Using media ranging from podcasts to infographics or comprehensive omnichannel campaigns, we can engage minds, harness opinion and encourage action. With women’s health companies such as Theramex and Organon having biosimilars as a key focus of their strategies, and newer biosimilars, biologics and bio-identicals emerging in the pipelines30, now is the perfect time to act to improve women’s healthcare.
By Duvaraka Alwar
