Biosimilars are copies of the original innovator drugs or Reference Listed Drugs (RLDs). Unlike generics they are not exact copies but according to US and EU definitions must be “highly similar” with no clinically meaningful differences from the RLD in terms of safety, purity, potency, and efficacy. However, because of the complexity and inability to demonstrate bioequivalence to originators, regulatory agencies require much more stringent and expensive head-to-head human trials for approvals. Biosimilar medicines may offer additional choices to patients with limited available treatment options while providing cost savings to health care systems around the world.
Biosimilars are well established in Europe and APAC where they have been in use for over fifteen years. In these regions, biosimilars have been approved for use across a wide range of therapeutic areas including diabetes, chronic kidney disease, Crohn’s disease, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, breast cancer, renal cancer, Leukemia, Non-Hodgkin’s lymphoma, and Turner Syndrome.
However, the development of the biosimilar market in the US, which is world’s largest market for biologics, has been slower. This is due to several factors including the relatively slow pace of the FDA to establish specific guidance on the development of biosimilars – the EMA approved the first biosimilar for use in the EU in 2006 while the FDA approved the first one for use in the US in 2015. Other factors include the relative strength of patent laws in the US, the complex health system structure, and the role of private insurers. In addition, the FDA has been slower to provide guidance on the issue of interchangeability.
Incentive policies developed by regulatory bodies in individual EU member states have had a strong influence in increasing biosimilar use in European markets. For example, in Norway and Denmark, regulatory authorities have been particularly proactive in encouraging the use of biosimilars. The issue of interchangeability (switching from biologic reference drug to biosimilar) has been significant, and this too is under the remit of individual member states. In Norway, (a pioneer in the clinical testing of the safety and efficacy of switching from RLD to biosimilar and back to RLD), specific guidance has been issued around interchangeability. It declared that there were no significant safety concerns about switching to biosimilars and further safety studies relating to interchangeability were not necessary. This guidance and proactive policies directed at educating physicians and patients about the use of biosimilars has led to an increased market share for these drugs and therapies.
Developing biosimilars is a complex and costly process. Pfizer estimates that it can take between $100 million and $250 million and five to nine years to develop a biosimilar. This compares to an estimated $1 million to $42 million and approximately two years for generic small-molecule drugs. This means sponsors need a reliable partner to help them navigate complex regulatory environments and to provide end-to-end solutions that can help biosimilar developers save time and reduce costs.
Cromos Pharma offers sponsors many advantages in the development of biosimilars. It has unparalleled experience in CIS and CEE markets that offer sponsors access to large naïve populations. It has a strong track record in rapid patient recruitment and retention necessary for biosimilar development including Phase 3 studies where 500-600 patients across several countries are often required. The most advanced regulatory agencies in the world routinely accept research data generated in our venues of Eastern and Central Europe, and our sites enjoy excellent reputations for high quality of data and successful regulatory audits. Cromos Pharma’s expertise in navigating both US and EU regulatory processes can also help biosimilar companies expedite evaluation and approval processes.
Contact the Cromos Pharma team today to discuss you next clinical project email: email@example.com
Throughout March we have been highlighting colorectal cancer, the amazing teams of researchers who are continuously fighting this disease, as well as the millions of patients and families who have been deeply affected by this silent killer. To close out this month of awareness-raising we want to introduce you to a real-life hero and colon cancer survivor - Arlene.
March is Colorectal Cancer Awareness Month. Colorectal cancer (CRC) is the third most common and second most deadly cancer worldwide according to 2020 figures from the Global Cancer Observatory.
Ukraine, the eight largest European country by population, is an attractive location for sponsors conducting clinical research for a number of key reasons. Cromos Pharma has been successfully managing clinical trials in Ukraine since 2006. This article looks at just some of the benefits of locating your next study here.
Cromos Pharma is continuously developing and looking to explore new territories when it comes to clinical research. In line with this spirit of discovery, we will be shortly commencing a new project in Uzbekistan supporting a study being conducted by the Swiss Tropical and Public Health Institute.
Cromos Pharma is delighted to be taking part in the upcoming DIA Europe conference (15 – 19 March 2021) and BIO-Europe Spring (22-25 March 2021).
February 11th is International Women and Girls in Science Day. A joint UNESCO and UN-Women initiative, it aims to promote the role of #WomenInScience and to challenge some of the barriers to girls pursuing a career in science.
Are you a sponsor seeking to conduct clinical trials in the European Union but do not have a registered office in the European Economic Area? If so, in order to comply with the European Union Clinical Trial Directive, you are required to work with a Legal Representative registered in an EEA country.
Each 4th February, #WorldCancerDay aims to raise awareness of the global personal, social and economic burden of cancer. World Cancer Day was established in Paris at the first World Cancer Summit in 2000.
As 2021 begins, many countries are grappling with a renewed surge of COVID-19 infections necessitating further public health restrictions putting more pressure on health systems, societies and global economies. The task of rolling out approved vaccines is increasingly urgent. Almost 16 million doses of COVID-19 vaccines have been administered to date in 37 countries worldwide according to data compiled by Bloomberg ( updated 7 Jan 2021).
Tuesday 1 December marked World AIDS Day 2020. Although throughout this year our focus has been on the coronavirus pandemic, World AIDS Day is an opportunity to reflect on another pandemic where a virus passed from animals to humans with devastating consequences. To date 77 million people worldwide have been infected with HIV. In spite of innovative new treatments 35 million people have died from the virus.
If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.