Abstract published: August 2021
Nowadays, almost one third new approvals for anticancer drugs are for biologics – and most of these are biosimilars. Considering this, an updated Policy Review published in The Lancet Oncology provides an analysis of potential barriers to market access for novel biosimilars and suggests ways to overcome them.
When biologics lose their patent protection, roll-out of biosimilars occurs quickly. However, since biosimilars first became available, quality concerns meant that the EMA initially rejected almost 1 in 10 new approval applications, the FDA rejected nearly half (44%), although the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have rejected none so far – albeit they received considerably fewer petitions.
In the EU, regulatory guidelines and risk tolerance are more lenient than in the USA, which is especially harsh on extrapolation of indications applications – that is, regulatory approval for a biosimilar in all the same settings as the originator biologic. This restriction clearly does not support market competition for biosimilars and should be addressed by federal legislation. Also in the USA, no biosimilar product has received a designation of interchangeability therefore biosimilars cannot be substituted for use at the pharmacy level. Automatic substitution is also prohibited in Japan, despite the practice being widespread in the EU, although Japan is urged to follow suit and liberalise its policy.
Patent litigation in the USA may discourage marketing even of approved biosimilars although this trend seems less apparent in the EU and Japan. One suggestion to reduce patent challenges is for settlements to be held via inter partes reviews, costing hundreds of thousands of dollars compared to millions for lawsuits.
Misconceptions about reduced safety and effectiveness of biosimilars compared with reference biologics are known to decrease market uptake of biosimilars. Further efforts should be focused on curtailing anti-competitive behaviour such as spreading misleading information by biologics manufacturers and for influential sources such as the American Society of Clinical Oncology (ASCO), the European Society For Medical Oncology (ESMO), and Japan’s Ministry of Health, Labour and Welfare to increase output of unbiased professional and societal education about biosimilars.
Pricing of biosimilars as determined by health systems in the EU, USA, and Japan varies: in each region discounts versus the cost of originator biologics range at around 10–30%. However, rebates and preferred positions in formularies often make biologics the cheapest option. Incremental cost-effectiveness determinations, and initiatives such as minimising pay-for-delay arrangements and making transparency of pricing agreements, are required further to enhance competition and affordability of biosimilars.
Key takeaway
The disinformation and misconceptions regarding the safety and effectiveness of biosimilars needs to be addressed promptly, while anti-competitive behaviour from pharmaceutical companies need to be curtailed. Transparency in pricing, rebates, and cost-effectiveness determinations are required to enhance competition and affordability of biosimilars.