Difficult-to-make medicines: making a difference in generics

Glossary 

Inhalers

Inhalers are advanced devices used to deliver medicine to the body via the lungs. They offer considerable benefits to patients suffering from diseases such as asthma. Inhalers come in two forms - metered dose inhalers (MDI) and dry powder inhalers (DPI). Both the complex application form and the demanding primary packaging place them in the category of difficult-to-make. Sandoz products include German market leader budesonide. Our Aeropharm unit, based in Rudolstadt, has a long history in the field.

Injectables

Injectable products account for nearly a quarter of the world pharmaceutical market, with the majority sold directly to hospitals. Injectables – in the form of ampoules, bottles and vials – require a sterile environment, special technology and rigorous quality systems and controls. Our Boucherville plant in Canada has a long history of manufacturing injectables and is the largest such plant in the country, with products ranging from painkillers, narcotics and sedatives through to antibiotics.

Transdermal patches

A transdermal patch is a medicated adhesive patch placed on the skin to deliver a time-released dose into the bloodstream. A wide variety of medicines can be administered this way. Fentanyl from Sandoz (for chronic pain relief) is a classic example of this difficult-to-make approach in action. The breakthrough technology, combined with a potency many times that of morphine, allows for controlled and long-lasting relief, and has made Fentanyl the market leader in both the US and Germany.

Implants

In pharmaceuticals, the term implant refers to subcutaneous (under the skin) delivery devices. Sandoz is a specialist in this complex field and recently launched an innovative new implant, leuprorelin, for use against prostate cancer. This new form is injected into the abdominal skin, releasing the active ingredient over a predefined period. Thanks to the special biodegradable materials, the implant itself need not be removed. Rival products are in micro-capsule or powder form and must be specially prepared by the doctor.

Biosimilars

Biosimilars, or follow-on proteins, are new versions of existing biopharmaceuticals whose patents have expired. They are produced using the same core genetic material and are approved on the basis that they are comparable to the reference product in terms of quality, safety and efficacy. They are large, complex protein molecules produced by living organisms. Biosimilars is an official term used by the European medical authorities; the US terminology is follow-on proteins (FOPP).

Biopharmaceuticals

Biotechnology is man’s use of the cell’s chemistry to produce therapeutically useful proteins in significant industrial quantities. Biopharmaceuticals are medicines produced using biotechnological methods. Living organisms are used to produce large and complex protein molecules, often using so-called recombinant technologies. It is estimated that, by 2010, 50% of newly approved medicines will be biopharmaceuticals.