Biosimilars/Research
Oncologists urged to embrace biosimilars to help control spiraling costs of cancer care
Oncologists have been urged to embrace biosimilar drug substitution to help control the spiraling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1].
The controversies surrounding biosimilars
It is well known that the introduction of similar biological medicinal products, or biosimilars, has caused not a little controversy in the medical world. The aim of healthcare providers/payers, either healthcare authorities or insurance companies, is to reduce the healthcare budget has risen in recent years through the introduction of expensive companion diagnostics, devices, and drugs. At the present moment this can only be achieved in two general ways: either the availability of therapies must be restricted from the patients who would benefit from them, or otherwise the costs of the procedures and drugs must be reduced to within affordable limits so that the majority of patients can benefit from them.
Study of biosimilar enoxaparins in Brazil
Analysis of biosimilar enoxaparins available for clinical use in Brazil by the Laboratório de Tecido Conjuntivo in Brazil have shown that the biosimilar preparations of enoxaprain are similar to the originator drug [1].
Biosimilars dilemma over reference products
Global manufacturers of biosimilars have a dilemma on their hands concerning reference products. What to do to reduce the burden of data required in different countries and regions of the world to get their biosimilars onto the market?
Current and future issues surrounding biosimilars
Biological medicines are already becoming an increasingly important part of health care. With patent expiries on originator biological products, biosimilars are also increasingly become a part of this future [1]. In fact, by 2020 twelve of the top-selling biologicals will have lost patent protection, opening up an estimated US$24 billion in EU sales and US$30 billion in US sales [2].
Reimbursement of biosimilars
The evidence required to obtain marketing authorisation for a biosimilar by the regulatory authority is not always the same as that required by the reimbursement authority [1]. This can cause problems for biosimilars manufacturers when planning clinical trials in order to obtain both marketing and reimbursement approval.
Comparability studies and substitution of biosimilars
In order to demonstrate similarity between the biosimilar and the biological reference product, both products must be compared to satisfy quality, safety and efficacy requirements [1].
Biosimilars: demonstrating ‘similarity’
Most biological drugs are mixtures of closely related compounds, some of which are probably more active than others. Today, the state-of-the-art manufacturing struggles to deliver material that is similar to the prior batch from the same facility and team [1]. Identical is currently not possible, therefore ‘similar’ is the route that authorities in Europe and the US are going down.
Registration of biosimilars in Europe and the US
Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006 [1].
EMA risk management plans may increase prescriber confidence in biosimilars
In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescriber confidence in the compounds [1].
