Realizing the benefits of Bio similar drugs and what we can learn from the European Markets
Bio similar drug, or biologics, are products which are produced from living organisms or their components brought together which are then used to treat a number of conditions such as diabetes, cancer, and immune system disorders. The production of Biologics ranges from relatively small molecule insulins, to monoclonal antibodies, to cell and gene therapies and are known as some of the most expensive and profitable money making drugs on the market. As a result, there has been an ongoing rush to create biosimilars that can compete with original biologic products and in the end produce large profits to the companies. The sole reason is to balance incentives for innovation with less costly access to these important biologic therapies.
The United States has started to accept legislation in order to create a process which is sustainable for regulating and approving biosimilars in the US. This new law has raised expectations that billions of dollars would be saved annually as multiple competitor biologics will enter in the market. As a result, the prices would be much lower as compared to the original drug.
Even after a decade later, the vision with which biosimilars were launched in the U.S. has not fully recognized its full potential. The reasons are not simple but rather complex and cover a large number of areas related to their entry in the US. But due to the uncertainties in the U.S. regulatory system which has created obstructions some of them being legal issues involving intellectual property. Other where the biosimilars are covered prevented by Medicare. This also depends on the issues managed by the biosimilar litigation attorney’s and clinicians and patient’s knowledge and acceptance of biosimilars, among other factors.
Meanwhile in other countries, most commonly seen in Europe region have moved more quickly to start developing biosimilars, and now have more than enough biosimilars on the market which are being used extensively. In countries where regimes governing drug regulation are different as compared to the US have copy right policy, pricing and payment policy. Many of these policies are not available or usable from one to another. Nevertheless, there are key takeaways which from the experience gained by biosimilar litigation attorney’s experiences do have relevance for the U.S.
This blog will highlight the best practices learned by biosimilar litigation attorney’s and how the biosimilar drugs create impact on the availability and their possible use of biosimilars in the U.S. and European markets. Now let’s explore what might be gained when you apply the European experience to the U.S. markets. We will also study how these steps will provide potential steps to increase the speed of biosimilars approvals and expand their usage in the U.S.
Biologic drugs are composed up of molecules used in large quantity which are derived from living organisms and further re-engineered in laboratories for consumption. They are usually much more complex than when its compared to small molecule drugs that are relatively simple to produce and their chemical compounds can be easily derived by chemical synthesis. Many biologics earlier are developed to treat various medical conditions that were previously difficult to treat some of them includes cancer, arthritis and Crohn’s disease. Similarly, the biologics are not just easily manufactured but are also expensive as compared to the smaller molecule drugs. Though the use of complex manufacturing processes that results in the variations of in each lot.
Pricing and Reimbursement Issues
According to biosimilar litigation attorney’s there is huge importance when it comes to the cost of the drug in the United States and Europe. Now manufacturers only need to consider the key to biosimilar adoption.
A key difference in the between the biologics in European systems and the U.S. is the degree of the bio similar drug. The nature of government handling the issue in the US market is different also when it comes to the price negotiation there is a huge difference in the regulation of the payers’ market in the US which also differs among European countries.
Some of the key things which biosimilar litigation attorney’s says can be derived from the mechanisms used in Europe is the pricing. The biosimilar drugs which are being sold at a percentage below the price of the originator and using a maximum price that is set by external (international) reference pricing. Other best practices which include manufacturers allowing them to charge prices at which they best want. When such products are launched and are being sold at a lower price reimbursement level for both an originator drug and its biosimilars.
According to the biosimilar litigation attorney’s as seen in the previous cases it is mandatory that the FDA-approved biosimilars should be of the same molecular formula when compared to the reference products. Also the FDA has underlined that they have no clinically proven differences from their reference biologic which distinguishes both the original drug from the reference drug.
Though the perceptions still remain that are clinically proven and meaningful differences exist between originators and biosimilars in both the United States and in Europe which can clearly differentiate between the two thus helping you to understand the difference between the bio similar.
In a recent survey perception of biosimilars among U.S. rheumatologists, most physicians are hesitant to switch patients from the reference product to the biosimilar when the patient is doing well on the reference product, but they are more likely to initiate biosimilar treatment for treatment-naïve patients.70 Yet as noted above, no major safety or effectiveness differences between originators and biosimilars have been demonstrated.
The EMA which holds the individual European country regulatory system and other stakeholders such as provider associations early understood that both physician and patient sides of the safety and efficacy of biosimilars could greatly affect their use when it comes to marketing them US. This resulted in European efforts to address these perceptions which addressed various approaches, including multi-stakeholder-, physician-, pharmacist- and patient-level education. How? the European Commission and the EMA stakeholders annually from different industries and political scopes discussing on the different areas related to biosimilars. This includes aligning on science-based messaging and addressing misinformation on biosimilars. The EMA also published a patient-focused initiative video which can be seen in multiple languages that explains how biosimilars are as safe and effective as their reference biologics as well as the EMA’s are planning to bring them to regulation.
Although health policies abroad have been developed and applied are different from the U.S when compared to the Europe. But there are substantial opportunities for growth in the U.S. that can be learnt from other nations’ experiences. And using the best practices that have excelled the use of biosimilars.
Lastly when it comes to bio similar market European and American policies have the same objective and goal that is to lower the cost of effective biologics. In European markets, biosimilars have achieved more popularity and public use without understanding the adverse events or proof how these are different from biosimilars and their reference biologics.
