Mylan expects to launch a generic version to EpiPen Auto-Injector (epinephrine injection, USP) in several weeks, pending completion of labeling revisions, the company said in a statement released on August 29, 2016. The product will be sold at a list price of $300 per two-pack carton, which represents a-more-than 50% discount to the Mylan list price, or wholesale acquisition cost of the branded medicine.

The authorized generic will be identical to the branded product, including device functionality and drug formulation. Upon launch, the product will be available as a two-pack carton in both 0.15 mg and 0.30 mg strengths. Mylan also intends to continue to market and distribute branded EpiPen.

Mylan announced the generic product following an announcement by the company earlier this month of making pricing adjustments for the branded product in the wake of several US senators calling for pricing reform for the product.

In commenting on the decision to launch the generic product, Mylan CEO Heather Bresch said in a company statement. “We understand the deep frustration and concerns associated with the cost of EpiPen to the patient and have always shared the public’s desire to ensure that this important product be accessible to anyone who needs it. Our decision to launch a generic alternative to EpiPen is an extraordinary commercial response, which required the cooperation of our partner. However, because of the complexity and opaqueness of today’s branded pharmaceutical supply chain and the increased shifting of costs to patients as a result of high deductible health plans, we determined that bypassing the brand system in this case and offering an additional alternative was the best option. Generic drugs have a long, proven track record of delivering significant savings to both patients and the overall healthcare system. The launch of a generic EpiPen, which follows the steps we took last week on the brand to immediately reduce patients’ out-of-pocket costs, will offer a long-term solution to further reduce costs and ease the burden and complexity of the process on the patient.”

Mylan said to enhance affordability for the broadest patient population possible, both the augmented patient-assistance program and the $300 savings card that were previously announced will remain in place for the brand product. Mylan will also continue its EpiPen4Schools program.

In addition, Mylan intends to initiate a direct-ship program in conjunction with the launch of the generic product at the $300 generic list price. Mylan also continues to work for enhanced access to epinephrine auto-injectors through other measures, such as inclusion of the product on the federal and private insurance preventive drug lists.

Source: Mylan