Opinion of Turkish League Against Rheumatism About Biosimilar Drugs

Today, biological drugs are important treatment options in inflammatory rheumatic diseases in our country as well as all over the world. Successful results are obtained in patients who cannot respond or tolerate conventional therapies, therefore prevention of disease-related complications and workforce loss and increase in the quality of life are possible. Biological drugs which ushered a new era in the treatment of rheumatic diseases have brought the term ‘targeted therapy’ and the target of treatment is now remission or, in some cases, low disease activity. 

In recent years, many of the original biological drugs that have been successfully used in the treatment of rheumatic diseases have been expired or expiration dates of their patents have come. The biosimilars of the original biological products were produced at a lower cost, therefore biosimilar drugs will be widely available in the pharmaceutical market in the coming period. 

The European Medicines Agency (EMA) first defined a legal approval process for biosimilar drugs in 2005 and updated the process with additional regulations to date. They reported that biosimilars could not be the same as the original molecule, however they should be similar in quality, safety and efficacy. American Food Drug Administration (FDA) defined the legal approval process in 2010 and issued a draft regulation in 2017 indicating additional requirements for replacing the biosimilar product with the original product. 

Licensing criteria for biosimilar drugs have been identified in ‘guide regarding biosimilar medical products’ which was published in Turkey in 2008. Increase in number of biosimilar drugs will reduce treatment costs and increase accessibility to the patients. However, clinicians need to be careful about the quality, safety and efficacy of biosimilar drugs. In the last 10 years, many articles have been published on the scientific and legal aspects of biosimilars, and regulations on the development of biosimilars.

The European League Against Rheumatism (EULAR) of which our association is a member, has prepared a guide on the use of biosimilars in rheumatic diseases. In this direction, our association shares the following opinions to ensure the safety of patients:

Overarching Principles: 

  1. The treatment of rheumatic diseases is based on the shared decision between the patient and the relevant specialist.
  2. The binding aspects of the health system should also be taken into account in the decision of the treatment.
  3. A biosimilar approved by FDA and/or the EMA and received a license from the Ministry of Health of the Republic of Turkey is not better or worse than its bio-original in terms of efficacy and it is not worse in terms of security.
  4. Patients and health care providers should be informed about the structure, approval process, safety and efficacy of biosimilars.
  5. Compatible methods should be established to obtain reliable pharmacovigilance data, including traceability on both the biosimilar and the original molecule.

Consensus Recommendations

  1. Accessibility to biosimilars should significantly reduce the cost of the treatment and increase access to optimal treatment for all patients with rheumatic diseases.
  2. Biosimilars approved by FDA and/or the EMA and received a license from the Ministry of Health of the Republic of Turkey can be used for the appropriate patients in the same way as their bio-originals. 
  3. Since there is no clinically significant difference between biosimilar and their bio-originals in terms of immunogenicity, it is not necessary to monitor anti-drug antibodies against biosimilars in clinical practice. Nevertheless, comparative immunogenicity data in clinical and post-market studies of biosimilars are important to enhance confidence among health care providers of biosimilars and should not be ignored completely.
  4. When phase III data on a biosimilar is published, preclinical and phase I data should also be available.
  5. A biosimilar is similar to its bio-original in terms of quality, biological activity, safety and efficacy in preclinical and clinical studies. Therefore, if the efficacy and safety of the biosimilar is confirmed for a single indication is, it can be concluded that it can be used for other diseases which its bio-original is approved.
  6. The present evidence shows that switching from the original to the biosimilar is safe and effective; there is no scientific basis to suggest that a different clinical result will be obtained by switching among the biosimilars of the same original molecule; however switching from the original molecule to the biosimilar or switching among biosimilars should be done by the physician, within the knowledge and consent of the patient.
  7. Multiple switching between biosimilars and bio-originals or among other biosimilars should be assessed by patient recording systems.

 

1.http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp

2.https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm

3.https://www.titck.gov.tr

4.Kay J, Schoel MM, Dörner T, Emery P,Kvien TK,Smolen JS et al.Consensus-based recommendations for the use of biosimilars to terat rheumatologic diseases. Ann Rheum Dis 2018;77:165-174.doi:10.1136/annrheumdis-2017-211937.