The evolving landscape of biosimilars – what ’ s going on ?
Since 2006 , approximately 60 biosimilar products across 15 different biological entities have been approved by the European Medicines Agency . Where are we going from here ?
Irene Krämer PhD Pharmacy Department , University Medical Center , Johannes Gutenberg- University , Mainz , Germany
The biosimilar market is still an exciting undertaking and business venture . During the past months , another striking event has been the introduction of several adalimumab biosimilars into the European market . Humira , the adalimumabcontaining reference product , has been number one on the top ten list of sales for many years , with more than $ 100 billion in total global sales . Adalimumab was the first fully human monoclonal antibody ( mAb ) licensed and is also the first one that will lose patent protection in Europe . However , the launch of adalimumab biosimilars was only possible after the license holder , Abbvie , granted several biosimilar companies a license to its intellectual property related to Humira . Through this agreement , a worldwide patent war , lasting many years , was settled . The license periods began in Autumn 2018 in most EU countries and will begin not earlier than 2023 in the US .
Thereby Abbvie could secure another five years of exclusivity over its >$ 10 billion US market for Humira . 1 Meanwhile , five adalimumab biosimilars have been launched in Germany and the European biosimilar market remains progressive . With over ten years ’ experience , the EU has the largest global biosimilar understanding . 2 The first biosimilar guidance came from the European Medicines Agency ( EMA ) in 2001 . Today most countries have valid regulations for the approval procedure of the followon products of recombinant biologics when the originator products come off patent . The upcoming patent expiry of the bevacizumab-containing Avastin ( Roche ) will shake up the oncology market once more . At that time , the three blockbuster mAbs in oncology pharmacy ( rituximab , trastuzumab and bevacizumab ) will be available as EMA-approved biosimilars .
Expenditures for biologics , especially mAbs , are huge across Europe . Patent expiry and market entry of biosimilars represent an opportunity to reduce the burden of underfinanced healthcare budgets . 2 Expiry of patent protection and competition by biosimilars usually favours reduction in price for the originator product and biosimilars . The competition between biosimilars of the same reference products puts additional pressure on pricing . The so-called late entry biosimilars of a reference product attempt market entry through a low-price policy . However , the uptake of biosimilars by the health care market in Europe differs from country to country and depends on the type of active biologic substance and treatment conditions . The economic efficiency of biosimilars depends on the regulations of the individual healthcare system , especially regarding the pricing and reimbursement structures . While the rates of discount generally amount to 90 % for generics , they often amount to less than 50 % for biosimilars . The main reason is high costs of the mandatory clinical studies . The payment of license fees for using the intellectual property of the originator company also has an impact on pricing . 1
Specialties of biosimilar regulation and use The acceptance of biosimilars among healthcare professionals and patients needs time , interaction and cooperation between healthcare professionals and patients . The type of interaction and cooperation depends on the specialties of the national healthcare system and regulations , which differ in the EU countries . In some countries , treatment of patients with biologics and biosimilars is exclusively performed in hospitals and the medicines are provided by hospital pharmacies . In other countries , these products are prescribed in outpatient clinics as well as private offices and provided by hospital pharmacies and / or local pharmacies .
Hospital pharmacists have embraced the topic and , for many years , have set prerogatives and conditions for the use of biosimilars in hospital patients . The hospitals ’ drug formulary committees often manage decisions about biosimilar use and product choice . Decisions are made based on a list of ten criteria relevant for clinicians and pharmacists and clinical practice . 3 These include : how long the drug had been on the market ; number of registered indications ; serious and mild adverse events and their frequency ; differing contraindications ; precautions or warnings compared with the reference compound ; ease of handling ; and reliability of the market authorisation holder , among others . While a general selection can be regarded as an important step forward , additional , more refined , selection matrices for specific groups of biosimilars are necessary and their implementation requires expert knowledge . Various parameters of biosimilars should be assessed specifically at a product level and a case-bycase basis . Important selection criteria for rituximab and trastuzumab biosimilars are vial sizes , storage conditions and stability data of the stock solutions and ready-to-administer infusion solutions . Important selection criteria for adalimumab biosimilars are the availability of ready-to-use syringes and pens and the functionality and the ease of use of the pens . The varying consequences deriving from initiating treatment with a biosimilar for naïve patients or switching experienced patients from the originator to a biosimilar , as well as multiple switches between the originator and one or more biosimilars , are not described in the current decision matrix system . However , these
4 | 2019 | hospitalpharmacyeurope . com