As biopharmaceutical technology becomes more widely used in the treatment of diseases such as rheumatology, cancer and other chronic diseases, professionals in the pharmaceutical industry predict that half of the newly approved drugs will soon come from biomedicine, which has also boosted a huge interest in developing biosimilars. The possibility of selling biopharmaceuticals that have passed the patent protection period is becoming more and more attractive to many biopharmaceutical companies, especially in the next few years, many biopharmaceuticals will lose patent protection.
Biogenerics (also known as biosimilars, follow-on proteins or follow-on biologics) are new copies of original biological products that have been approved by law. Unlike common generic, FDA defines common generics as: A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. While biosimilars are macromolecules made from biological organisms and their products, usually macromolecules with high complexity. In addition, the differences between the two include that chemical generics are often very stable, while biosimilars are very sensitive to changes in production processes.
Patients and doctors may prefer original brand drugs than biosimilars, or they need sufficient proof to show that they have the same efficacy and safety. As a biosimilar manufacturer, it has no access to the same cell bank, molecular cloning, and the exact fermentation and purification process used in the development of the original drug, and the production process cannot be reproduced. In order to ensure full confidence in biosimilars, regulations are needed to reduce users' concerns about the different performance of biosimilars compared to the original drug. Unlike chemical generics, each biosimilar requires clinical trials because even small differences in product impurities, decomposition materials, or molecular makeup can cause serious health problems in patients.
Biosimilar R&D Outsourcing
The global biosimilars market is expected to grow rapidly in the next few years, which will also put tremendous pressure on biopharmaceutical companies because they want to gain a corresponding market position in this new and highly competitive field. The production of biosimilars requires professional competence, rigorous planning, highly professional staff and huge investments. Investments in sites, equipment, technology, materials, and manpower can increase company pressure, consume company resources, and reduce overall business success. For this reason, companies that want to produce biosimilars in an efficient way, without having huge investments in expensive high-tech equipment, are increasingly using entrusted contract manufacturing companies (CMOs) or contracts. The way of research organizations (CROs) that provide services and have a well-trained team of professionals and advanced technology to develop relevant analytical methods and processes for bio-manufacturing.
To ensure that the biosimilar approval process is more effective and that it can enter the market faster, some pharmaceutical companies are beginning to collaborate with contract research organizations (CRO) that offer a full range of processes from drug development, preclinical testing and clinical trials. This can be combined with preclinical evaluation, research circuit design, clinical trial management, data collection, statistical analysis and product compliance with regulatory requirements. In addition to a wealth of programs, technologies, equipment and personnel, contract research organizations can also provide more comprehensive expertise, especially in the experience of the original biological product development process.
One of the biggest advantages of outsourcing is to reduce the pressure on the company, so that pharmaceutical companies can focus on innovative products or develop products with higher profits. In addition, outsourcing is also very beneficial for capital use efficiency because it allows biopharmaceutical companies to invest their R&D most cost-effectively, without the need for biosimilar products to demonstrate regulatory approval and market prospects.
Some companies are highly specialized in certain technologies, such as mass spectrometry to analyze biological products. For biosimilars, these companies can also perform comparative analysis with reference products and provide high-quality immunobiological analysis services, including enzyme-linked immunosorbent assays (ELISAs), radioimmunoassays (RIAs), and multiple Meso Scale assays. From a clinical trial perspective, outsourcing companies can provide a more comprehensive set of technologies, including data management systems, electronic data records (EDC), and risk management programs that can be implemented through tracking systems, such as network-based patient registration to identify potential safety hazards. And the risk of immunogenicity that is less pronounced in preclinical and clinical trials.
For biopharmaceutical companies, developing biosimilars has great market opportunities and challenges, and outsourcing to contract research organizations can enable companies to implement the fastest and most cost-effective way to introduce new products to the market. The knowledge, expertise, industry understanding and technology, skills and financial controls of a contract research organization are a solution that can benefit many companies.
With the development of industry, the development of globalization will be of great significance for pharmaceutical companies to maintain competitiveness and financial health. This is also the only viable way to increase the effectiveness of biopharmaceuticals worldwide and to make them affordable and accessible. The European Generic Drugs Association (EGA) recommends that in order to achieve this goal, a scientific approach should be adopted to achieve globalization, so that regulatory approvals can be obtained in major markets.
From this time on, there will not be too many new entrants entering the Western market, only those that can develop high quality formulas more cost-effectively, and meet the approval of the European Medicines Agency and the US Food and Drug Administration. Enterprises can occupy this area.
Profacgen laboratories are dedicated to offer comprehensive one-stop services for pre-clinical drug development, including pharmacology/toxicity studies as well as chemistry, manufacturing and controls (CMC) services worldwide, which aim to evaluate and improve the efficacy and safety of new drug candidates. The wide range of services provided by Profacgen aim to deliver an integrated platform for every step of drug development – from early-stage research all the way to commercialization. Its preclinical and CMC teams work closely with the clients to ensure that every project receives the attention it needs. All of its services are designed and executed in compliance with international regulatory requirements to support your clinical development and regulatory plans.
Profacgen also provides a one-stop solution for biosimilar testing, including Toxicology, TK and Immunogenicity assessment. The company has developed more than a dozen biologics/ biosimilar for toxicology studies. Ranging from determining the exact sequence, structure and quality attributes of the originator to comparative head-to-head biosimilarity testing of the biosimilar with the originator, its biosimilar testing services provide vital analytics.