What is the difference between domestically produced rasagiline/Azilate and imported rasagiline?

Rasagiline/Azilect was first developed and launched by the Israeli pharmaceutical company Teva (Teva) under the trade name Azilect. Later, many international pharmaceutical companies also launched its generic versions. With the increasing demand for this drug from patients with Parkinson's disease, domestically produced rasagiline has gradually entered the market. Currently, many pharmaceutical companies in China are producing this drug, including Qilu Pharmaceuticals, Chia Tai Tianqing, etc. There are certain differences between domestically produced and imported rasagiline in terms of production technology, efficacy, safety and price.

In terms of active ingredients, both the domestic rasagiline and the imported version are rasagiline mesylate. Their main mechanism of action is the same, which is to selectively inhibit monoamine oxidaseB (MAO-B), reduce dopamine degradation, and improve the symptoms of Parkinson's disease. Theoretically, as long as it meets the bioequivalence standards of agencies such as the National Medical Products Administration or the U.S. Food and Drug Administration (FDA), the efficacy of domestically produced rasagiline should be comparable to the imported version.

In terms of production technology and excipients, imported rasagiline may have more advantages in terms of impurity control, stability and dissolution because the original manufacturer has complete research and development data. The domestic version can usually reach similar standards to imported drugs after the consistency evaluation is completed. Some domestic manufacturers may even improve tablet disintegration speed and gastrointestinal tolerance after process optimization.

In terms of price, imported rasagiline is often more expensive due to higher patents, import taxes and production costs. However, after the domestic version enters the market, the price is usually more competitive, allowing more patients to afford long-term treatment. In addition, some domestically produced rasagiline has been included in the national medical insurance catalog, which has reduced the financial burden of patients to a certain extent, while the imported version may have higher out-of-pocket costs due to its higher price and limited medical insurance reimbursement ratio.

Reference materials:https://www.azilect.com/