A view on biosimilars – a status update and the impact on pharmacovigilance

In our latest blog, Philipp Hofmann, Director - Pharmacovigilance & QPPV, provides a status update on Biosimilars and their impact on pharmacovigilance.

Philipp Hofmann

Director
Pharmacovigilance & QPPV,

Navitas Life Sciences

The world of Biosimilars continues to Evolve and Grow

Looks the same, tastes at least similar: In the supermarket, you can find quite a few products that resemble successful brands but are much cheaper. A sales strategy that has proven successful for ice cream - and knows hardly any limits.

Similiarly, there are generic products for numerous well-known medications. In the pharmaceutical world, the effect is important, not the taste. Whether the drug comes from a major Western pharmaceutical company, a generic manufacturer or a no-name producer usually makes no difference. In the case of conventional drugs against hypertension or a coagulation inhibitor, the active ingredients are identical, for example the well-known painkiller Aspirin and acetylsalicylic acid (ASA).

The first biopharmaceuticals came into the market 40 years ago. Around 200 biopharmaceutical substances are now approved: as hormones and vaccines, for the treatment of cancer and autoimmune diseases, as coagulation factors and anti-inflammatory agents.

However, biologics are expensive: a therapy can cost up to 25,000 euros per year and patient. And people suffering from diabetes, rheumatism or cancer are usually dependent on treatment for several years or even for life. That's why cheaper alternatives are in high demand. As patent protection gradually expires, generic drugs are entering the market; the first of these biosimilars have been available since 2006. On European markets, there are now a total of 86 approved biosimilars for 16 biologic active ingredients; in average 30 percent cheaper than the originals. The pricing remains on a certain level, as the development of a biosimilar takes eight to ten years and the manufacturing process remains expensive.

Like the original, a biosimilar is intensively tested before marketing authorisation approval. Only if its efficacy and safety are comparable to those of the original, it is approved for the market. The European Medicines Agency EMA therefore emphasized in a statement in September 2022¹ that an exchange was harmless with regard to these criteria.

Biosimilars continue to post immense growth. According to a McKinsey report, the biosimilars market is expected to reach 30$ billion by 2025, and by the end of the decade, a 60$ billion.

A Focus on Safety of Biosimilars

In terms of pharmacovigilance for the pharmaceutical companies for both innovator biologics and biosimilars, an advanced pharmacovigilance system needs to be in place to reflect the complexity of safety data and challenges in the detection of ADRs for biosimilars from all sources. The interchangeability of products is an additional challenge: A biosimilar can be used in place of another biosimilar of the same reference product.²

For reporting of ADRs for biologics, it is not mandatory to provide a brand name and batch number of the product in India and the USA; however, the European Union (EU) regulations mandate to provide a brand name and batch number of the product. Specific rules for periodic reporting apply depending on the geographical regions³. Periodic reports on the safety of biosimilars in the years after market authorization are mandatory. It is recommended connecting reported ADRs with specific batches of the biosimilar for comparison with the reference product and documenting patient history with the reference product when assessing immunogenicity or lack of efficacy.⁴

The political pharmaceutical discussion is ongoing since 2018. Changes in legislation are now expected to be made by August 2023.

A NETWORK OF EXPERIENCED QPPVS FOR GLOBAL AND LOCAL QPPV NEEDS

A Qualified Person for Pharmacovigilance (QPPV) is personally responsible, by law, for the safety of the human pharmaceutical products marketed by that company in the EU. The QPPV should reside in the EU and provide support across the globe through in-house QPPVs and a network of Local QPPVs.

When choosing a QPPV partner, it is important to select a partner with access to the best local experts, and who can provide scalable and customized solutions based on specific needs. Navitas Life Sciences provides integrated and end-to-end solutions that extend beyond QPPV and include comprehensive management of safety reporting, lucid communications, and effective support to all stakeholders.

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