David Henry, MD, FACP

Biosimilars have arrived, and chances are that you’re already prescribing them. Last September, the US Food and Drug Administration (FDA) approved the first cancer-specific biosimilar, bevacizumab-awwb, for multiple cancer types (p. e60);¹ and in November, it approved trastuzumab-dkst for HER2-positive breast and gastrointestinal cancers (p. e63).¹ Briefly, biosimilars are biologic products that show comparable quality, efficacy, and safety to an existing, approved biologic known as the reference product.

Small-molecule drugs such as aspirin are easy to replicate identically, whereas biosimilars are large, complex proteins that are manufactured in nature’s factory, a micro-organism or biologic cell.² The manufacturing process must be nearly identical to that for the reference product, so that only insignificant/nonclinically significant impurities occur in the final product. The protein-amino acid sequence is key and must therefore be identical. The 2010 Biologics Price Competition and Innovation Act established an abbreviated pathway for the FDA to consider and approve biosimilars, and 5 years later, the bone marrow stimulant filgrastim-sndz became the first biosimilar approved for use in the United States.³ The development of biosimilars is not inexpensive. The law and the FDA approval system require preclinical and phase 1 testing, and a robust phase 3 trial against the reference product to demonstrate that safety and efficacy are statistically not different and that any chemical differences between the biosimilar and reference product are clinically and safety or immunogenically insignificant. When those criteria have been met, and the biosimilar approved, the clinical and cost benefits to patients could be significant. In general, the cost of a biosimilar is about 20% to 30% lower than that of the reference product.

Biosimilarity does not yet allow interchangeability. Small-molecule generics under FDA regulations are interchangeable in the drug store and the hospital without the prescriber or patient being aware. That is not yet the case with biosimilars, but their lower prices could have a notable impact on overall cost of care. In 2013, 7 of the top 8 best-selling drugs in the global market were biologics.⁴ Three of the top 8 – rituximab, trastuzumab, and bevacizumab – were used to treat cancer, and 1 (pegfilgrastim) was for therapy-related neutropenia. Their total cost was US$27 billion. Biosimilars of those therapies could significantly lower that amount.

Nabhan and colleagues interviewed 510 US-based community oncologists about their understanding of biosimilars. They found that only 29% of respondents said they prescribed filgrastim-sndz for supportive care by personal choice, but upward of 73% said they would prescribe biosimilars for the active anticancer therapies, trastuzumab and bevacizumab. There’s no question that biosimilars are here to stay. The requirements to make them have been well worked out. Their safety and efficacy therefore can be assured, and their lower prices promise cost savings for patients and society as a whole.

Biosimilars have arrived, and chances are that you’re already prescribing them. Last September, the US Food and Drug Administration (FDA) approved the first cancer-specific biosimilar, bevacizumab-awwb, for multiple cancer types (p. e60);¹ and in November, it approved trastuzumab-dkst for HER2-positive breast and gastrointestinal cancers (p. e63).¹ Briefly, biosimilars are biologic products that show comparable quality, efficacy, and safety to an existing, approved biologic known as the reference product.

Small-molecule drugs such as aspirin are easy to replicate identically, whereas biosimilars are large, complex proteins that are manufactured in nature’s factory, a micro-organism or biologic cell.² The manufacturing process must be nearly identical to that for the reference product, so that only insignificant/nonclinically significant impurities occur in the final product. The protein-amino acid sequence is key and must therefore be identical. The 2010 Biologics Price Competition and Innovation Act established an abbreviated pathway for the FDA to consider and approve biosimilars, and 5 years later, the bone marrow stimulant filgrastim-sndz became the first biosimilar approved for use in the United States.³ The development of biosimilars is not inexpensive. The law and the FDA approval system require preclinical and phase 1 testing, and a robust phase 3 trial against the reference product to demonstrate that safety and efficacy are statistically not different and that any chemical differences between the biosimilar and reference product are clinically and safety or immunogenically insignificant. When those criteria have been met, and the biosimilar approved, the clinical and cost benefits to patients could be significant. In general, the cost of a biosimilar is about 20% to 30% lower than that of the reference product.

Biosimilarity does not yet allow interchangeability. Small-molecule generics under FDA regulations are interchangeable in the drug store and the hospital without the prescriber or patient being aware. That is not yet the case with biosimilars, but their lower prices could have a notable impact on overall cost of care. In 2013, 7 of the top 8 best-selling drugs in the global market were biologics.⁴ Three of the top 8 – rituximab, trastuzumab, and bevacizumab – were used to treat cancer, and 1 (pegfilgrastim) was for therapy-related neutropenia. Their total cost was US$27 billion. Biosimilars of those therapies could significantly lower that amount.

Nabhan and colleagues interviewed 510 US-based community oncologists about their understanding of biosimilars. They found that only 29% of respondents said they prescribed filgrastim-sndz for supportive care by personal choice, but upward of 73% said they would prescribe biosimilars for the active anticancer therapies, trastuzumab and bevacizumab. There’s no question that biosimilars are here to stay. The requirements to make them have been well worked out. Their safety and efficacy therefore can be assured, and their lower prices promise cost savings for patients and society as a whole.

Biosimilars have arrived, and chances are that you’re already prescribing them. Last September, the US Food and Drug Administration (FDA) approved the first cancer-specific biosimilar, bevacizumab-awwb, for multiple cancer types (p. e60);¹ and in November, it approved trastuzumab-dkst for HER2-positive breast and gastrointestinal cancers (p. e63).¹ Briefly, biosimilars are biologic products that show comparable quality, efficacy, and safety to an existing, approved biologic known as the reference product.

Small-molecule drugs such as aspirin are easy to replicate identically, whereas biosimilars are large, complex proteins that are manufactured in nature’s factory, a micro-organism or biologic cell.² The manufacturing process must be nearly identical to that for the reference product, so that only insignificant/nonclinically significant impurities occur in the final product. The protein-amino acid sequence is key and must therefore be identical. The 2010 Biologics Price Competition and Innovation Act established an abbreviated pathway for the FDA to consider and approve biosimilars, and 5 years later, the bone marrow stimulant filgrastim-sndz became the first biosimilar approved for use in the United States.³ The development of biosimilars is not inexpensive. The law and the FDA approval system require preclinical and phase 1 testing, and a robust phase 3 trial against the reference product to demonstrate that safety and efficacy are statistically not different and that any chemical differences between the biosimilar and reference product are clinically and safety or immunogenically insignificant. When those criteria have been met, and the biosimilar approved, the clinical and cost benefits to patients could be significant. In general, the cost of a biosimilar is about 20% to 30% lower than that of the reference product.

Biosimilarity does not yet allow interchangeability. Small-molecule generics under FDA regulations are interchangeable in the drug store and the hospital without the prescriber or patient being aware. That is not yet the case with biosimilars, but their lower prices could have a notable impact on overall cost of care. In 2013, 7 of the top 8 best-selling drugs in the global market were biologics.⁴ Three of the top 8 – rituximab, trastuzumab, and bevacizumab – were used to treat cancer, and 1 (pegfilgrastim) was for therapy-related neutropenia. Their total cost was US$27 billion. Biosimilars of those therapies could significantly lower that amount.

Nabhan and colleagues interviewed 510 US-based community oncologists about their understanding of biosimilars. They found that only 29% of respondents said they prescribed filgrastim-sndz for supportive care by personal choice, but upward of 73% said they would prescribe biosimilars for the active anticancer therapies, trastuzumab and bevacizumab. There’s no question that biosimilars are here to stay. The requirements to make them have been well worked out. Their safety and efficacy therefore can be assured, and their lower prices promise cost savings for patients and society as a whole.

With this issue of COMMUNITY ONCOLOGY, memories of this year’s annual meeting of the American Society of Clinical Oncology in Chicago are starting to fade, but we are still trying to make sense of the wealth of data that was presented there. I found a number of the presentations particularly noteworthy and some of the findings likely to have an impact on how we practice. The aTTom trial1 by a group of British researchers was presented at the plenary session and dovetailed nicely with the ATLAS trial² findings that were presented at last year’s San Antonio Breast Cancer Symposium. Both trials examined 5 and 10 years of adjuvant tamoxifen in women with early stage, hormone-positive breast cancer, and findings from both trials showed reductions in recurrence, breast cancer mortality, and overall mortality in women who remained on tamoxifen to year 10. Two presentations examined frequency of scanning in Hodgkin and non-Hodgkin lymphoma and both groups of researchers concluded what many of us have often suspected – that we overscan, and that clinical surveillance is an adequate strategy for detecting recurrence. One study showed that most diffuse large B-cell lymphoma relapses were found by detection of symptoms during a physical exam, lab abnormalities, or even the patients themselves, and that routine surveillance scans did not add much to the detection of relapse.³ Findings from a second study showed that routine surveillance did not result in any survival advantage in patients with classical Hodgkin lymphoma who had achieved complete remission.⁴

With this issue of COMMUNITY ONCOLOGY, memories of this year’s annual meeting of the American Society of Clinical Oncology in Chicago are starting to fade, but we are still trying to make sense of the wealth of data that was presented there. I found a number of the presentations particularly noteworthy and some of the findings likely to have an impact on how we practice. The aTTom trial1 by a group of British researchers was presented at the plenary session and dovetailed nicely with the ATLAS trial² findings that were presented at last year’s San Antonio Breast Cancer Symposium. Both trials examined 5 and 10 years of adjuvant tamoxifen in women with early stage, hormone-positive breast cancer, and findings from both trials showed reductions in recurrence, breast cancer mortality, and overall mortality in women who remained on tamoxifen to year 10. Two presentations examined frequency of scanning in Hodgkin and non-Hodgkin lymphoma and both groups of researchers concluded what many of us have often suspected – that we overscan, and that clinical surveillance is an adequate strategy for detecting recurrence. One study showed that most diffuse large B-cell lymphoma relapses were found by detection of symptoms during a physical exam, lab abnormalities, or even the patients themselves, and that routine surveillance scans did not add much to the detection of relapse.³ Findings from a second study showed that routine surveillance did not result in any survival advantage in patients with classical Hodgkin lymphoma who had achieved complete remission.⁴

With this issue of COMMUNITY ONCOLOGY, memories of this year’s annual meeting of the American Society of Clinical Oncology in Chicago are starting to fade, but we are still trying to make sense of the wealth of data that was presented there. I found a number of the presentations particularly noteworthy and some of the findings likely to have an impact on how we practice. The aTTom trial1 by a group of British researchers was presented at the plenary session and dovetailed nicely with the ATLAS trial² findings that were presented at last year’s San Antonio Breast Cancer Symposium. Both trials examined 5 and 10 years of adjuvant tamoxifen in women with early stage, hormone-positive breast cancer, and findings from both trials showed reductions in recurrence, breast cancer mortality, and overall mortality in women who remained on tamoxifen to year 10. Two presentations examined frequency of scanning in Hodgkin and non-Hodgkin lymphoma and both groups of researchers concluded what many of us have often suspected – that we overscan, and that clinical surveillance is an adequate strategy for detecting recurrence. One study showed that most diffuse large B-cell lymphoma relapses were found by detection of symptoms during a physical exam, lab abnormalities, or even the patients themselves, and that routine surveillance scans did not add much to the detection of relapse.³ Findings from a second study showed that routine surveillance did not result in any survival advantage in patients with classical Hodgkin lymphoma who had achieved complete remission.⁴

I have just returned from the Oncology Practice Summit, the annual conference for practice-based oncologists and midlevels, which was hosted by COMMUNITY ONCOLOGY and its sister publications, THE JOURNAL OF SUPPORTIVE ONCOLOGY (JSO) and THE ONCOLOGY REPORT, in Las Vegas. During my flight to the conference, I noticed that there was a certain buzz among the passengers, which I naturally assumed was about our oncology meeting. But as I looked around, I realized that not only was I the only passenger who was wearing a tie, I was also the only one who had knocked back less than one drink. The frenzy was about the first weekend of the NCAA’s March Madness, and the pervasive enthusiasm among the passengers revolved around the wellknown “science” of bracketology, in which basketball enthusiasts take all 64 teams in the tournament and try to predict which team will win each match as the teams work their way down to the Final Four and ultimately, to the winner. President Obama had already said that his pick was Indiana (we know now how that turned out — sorry Indiana), but the amateur handicappers on the plane were still sifting through the teams’ records and the coaches’ and individual players’ strengths and weakness to bet (upon their arrival in Las Vegas) on which team would ultimately prevail. Once in Las Vegas, we managed to have our conference despite the March Madness mayhem, and in the course of the meeting, the term bracketology took on an oncology-tinged relevance for me. Bear with me.

I have just returned from the Oncology Practice Summit, the annual conference for practice-based oncologists and midlevels, which was hosted by COMMUNITY ONCOLOGY and its sister publications, THE JOURNAL OF SUPPORTIVE ONCOLOGY (JSO) and THE ONCOLOGY REPORT, in Las Vegas. During my flight to the conference, I noticed that there was a certain buzz among the passengers, which I naturally assumed was about our oncology meeting. But as I looked around, I realized that not only was I the only passenger who was wearing a tie, I was also the only one who had knocked back less than one drink. The frenzy was about the first weekend of the NCAA’s March Madness, and the pervasive enthusiasm among the passengers revolved around the wellknown “science” of bracketology, in which basketball enthusiasts take all 64 teams in the tournament and try to predict which team will win each match as the teams work their way down to the Final Four and ultimately, to the winner. President Obama had already said that his pick was Indiana (we know now how that turned out — sorry Indiana), but the amateur handicappers on the plane were still sifting through the teams’ records and the coaches’ and individual players’ strengths and weakness to bet (upon their arrival in Las Vegas) on which team would ultimately prevail. Once in Las Vegas, we managed to have our conference despite the March Madness mayhem, and in the course of the meeting, the term bracketology took on an oncology-tinged relevance for me. Bear with me.

I have just returned from the Oncology Practice Summit, the annual conference for practice-based oncologists and midlevels, which was hosted by COMMUNITY ONCOLOGY and its sister publications, THE JOURNAL OF SUPPORTIVE ONCOLOGY (JSO) and THE ONCOLOGY REPORT, in Las Vegas. During my flight to the conference, I noticed that there was a certain buzz among the passengers, which I naturally assumed was about our oncology meeting. But as I looked around, I realized that not only was I the only passenger who was wearing a tie, I was also the only one who had knocked back less than one drink. The frenzy was about the first weekend of the NCAA’s March Madness, and the pervasive enthusiasm among the passengers revolved around the wellknown “science” of bracketology, in which basketball enthusiasts take all 64 teams in the tournament and try to predict which team will win each match as the teams work their way down to the Final Four and ultimately, to the winner. President Obama had already said that his pick was Indiana (we know now how that turned out — sorry Indiana), but the amateur handicappers on the plane were still sifting through the teams’ records and the coaches’ and individual players’ strengths and weakness to bet (upon their arrival in Las Vegas) on which team would ultimately prevail. Once in Las Vegas, we managed to have our conference despite the March Madness mayhem, and in the course of the meeting, the term bracketology took on an oncology-tinged relevance for me. Bear with me.