About Spear Pharmaceuticals

For more than 20 years, Spear Pharmaceuticals has been committed to making FDA-approved bioequivalent and branded products accessible to the public. The Spear doctrine for bioequivalent drugs is to utilize the same active and inactive ingredients, as well as the same texture, look and consistency, as the branded product. Our commitment to quality has resulted in FDA approval of eleven first-to-market bioequivalent dermatological products, with several more in the pipeline.

Spear Pharmaceuticals is a proud member of the Generic Pharmaceutical Association (GPhA).

History of Spear Pharmaceuticals

Spear Pharmaceuticals, founded by K.L. Spear, M.D., in 1993, is a company that develops specialty dermatological products to fulfill market needs. Dr. Spear started the firm after 20 years working with patients, and seeing firsthand the improvement he could effect in their skin, and how that change for the better could enhance their lives. He believed that helpful, effective medications should be kept available for all patients. By combining his formal training at the Mayo Clinic with his practical experience, Dr. Spear now helps thousands of patients at a time by making and marketing bioequivalent products people need.

Dr. Spear’s mission was formed when he realized there was no generic bioequivalent for one of dermatology’s biggest products. He knew from his everyday medical practice the kind of positive impact he could provide to his patients, and believed from his clinical trial experience at the Mayo clinic that it would be possible to develop an affordable alternative to Retin-A®. And, of course, he knew what kind of benefits he could provide, not only to the patients who came to his office, but to people everywhere.

That was the genesis of the dermsmallprocess, which designs and develops bioequivalent drugs that have the same active and inactive ingredients, the same texture, look and consistency as the branded product. The Spear doctrine is to produce quality bioequivalent products with characteristics that meet a dermatologist’s demanding specifications. We prefer the term bioequivalent over generic because it better explains our process.

Spear has extensive experience with dermatologic compounds from both the clinical and technical perspectives. Tretinoin is one such compound, for which Spear introduced the first FDA-approved generic bioequivalent versions of Retin-A®, Renova®, and most recently Retin-A Micro®. Since 2001, pharmacies around the country have dispensed over a million prescriptions containing Spear’s tretinoin. The Spear generic to Renova® was converted to Refissa® and is now sold by Suneva Medical.

Working with seasoned drug industry professionals covering the disciplines of research and development, quality, manufacturing, regulatory, sales and marketing, Dr. Spear has fulfilled his vision of making FDA-approved bioequivalent drugs accessible to the public. In 1998 after only 5 years, Spear obtained its first approvals, becoming the smallest pharmaceutical company ever to receive an FDA approval. To date, Spear has earned FDA approval for 11 first-to-market bioequivalent dermatologicals, and has several more in the pipeline.

Spear Pharmaceuticals is responsible for all technical aspects of the corporation, including manufacturing, regulatory, quality control, and research and development.

Spear Dermatology Products is the sales, marketing, and distribution arm of Spear Pharmaceuticals.

Experience

K.L. Spear, M.D., President and Dermatologist
Bob Sarrio, Sr. VP Scientific and Quality Affairs
David Christ, Sr. VP Regulatory
Lorri Renaud, VP Project Management
Rachel Spear Phillips, PharmD, MS, VP New Product Development