MedCity Influencers

Winning Against Cancer with Safe and Effective Treatments

The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990.  These promising reductions in the mortality rate are most apparent in lung, colon, breast, and prostate cancers, the most […]

The marathon battle against cancer continues but we are winning. New statistics from the American Cancer Society show the number of cancer-related deaths has decreased by about 23% in men and 15% in women since 1990.  These promising reductions in the mortality rate are most apparent in lung, colon, breast, and prostate cancers, the most prevalent types, but there are also improvements for patients with rarer ones.

This is exciting news to the Colon Cancer Alliance, as we are committed to ending the pain and suffering caused by colorectal cancer.

Increased preventative measures and greater screenings explain in part the improvement in survivorship rates.  Another reason is our better understanding of cancer.  This has enabled the development of advanced biotech medicines, or biologics, which are now at the forefront of treatment.

To put things in perspective, when my mother was diagnosed with colon cancer in 1998 there was only one drug available to combat it and very little research and development dedicated to colon cancer.   Today, by contrast, there are eight drugs, with more in the pipeline.

So how do biologics work? Some obstruct the blood supply that feeds tumor growth and development.  Others, like monoclonal antibodies, bind to tumors to stop their growth.  These advanced medicines are nothing short of miracle drugs, restoring hope to patients.

Soon imitative versions of biologics, known as biosimilars, will be available in the United States.  Biosimilars are similar, though nonidentical versions of existing biologic medicines.  In 2010, Congress authorized the U.S. Food and Drug Administration to devise a plan to approve biosimilars and their market entrance may increase the accessibility of current cancer treatments.  The thinking behind the legislation is that biosimilars will offer modest but important cost savings – estimated up to 30%.

Yet biosimilars will only be broadly embraced if they are as safe and effective as their innovator counterparts. This class of medicines is much more complex than traditional drugs as they are produced in living organisms rather than chemically synthesized.  For scale, biologic molecules are typically thousands of times larger than chemical molecules.

sponsored content

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

Biotech medicines are also highly sensitive to the production process and impossible to duplicate exactly.  While chemical drugs use the same raw materials as their generic forms, biologics do not.  Additionally, the multiple manufacturing steps present many places where their development can go awry – and cause adverse effects in patients. It is therefore crucial that biosimilars are held to same level of scrutiny as innovator products.

Within weeks, the Food and Drug Administration (FDA) is expected to release guidance documents that will begin to establish the process manufacturers must follow when seeking approval for biosimilars.   To protect the safety of all patients, the FDA must incorporate specific measures such as exhaustive clinical and nonclinical measures including unique names, distinctive labels, and helpful product codes to properly distinguish between biological products and respond to potential problems.  Additionally, these rules should make sure that the treating physician is notified of any changes to the treatment prescribed, including any adverse events.

With cancer, there is no ‘magic bullet’ – only a number of strategies.  Biologics continue to offer cutting-edge defense against cancer.  Biosimilars will also expand the opportunity for cancer patients to seek treatment.  Yet biosimilars must be as effective and safe as their biologic counterparts.  With the introduction of safe biosimilars on the market, we hope to see an ever-decreasing number of cancer-related deaths.

Andrew Spiegel is Chief Executive Officer of the Colon Cancer Alliance (CCA), a national patient advocacy organization dedicated to ending the suffering caused by colorectal cancer.  CCA is a member of the Alliance for Safe Biologic Medicines.

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.