ASBM Biosimilars

1. ASBM Biosimilars US Prescribers and Biosimilars Naming Kevin Olson, CEO Industry Standard Research KevinO@ISRreports.com October, 2015

2. Table of contents Page 3 Methodology 12Drug Recording Practices 20Product Naming Attitudes and Beliefs 32Substitution Attitudes and Beliefs ASBM - US Prescribers and Biosimilars Naming

3. ASBM Methodology

4. Study methodology • 400 prescribers • 15-minute web-based survey • All participants based in the U.S. • Participants recruited from large, global panel of healthcare professionals • Participants screened as follows: • Specialize in one of 7 therapeutic specialties, including: Dermatology, Endocrinology, Gastrointestinal, Nephrology, Neurology, Oncology, Rheumatology • Must have been in practice for 1 year or more • Participants received a standard cash stipend for their time • Study was sponsored by ASBM and administered by Industry Standard Research, LLC ASBM - US Prescribers and Biosimilars Naming

5. Sample characteristics Practice Setting Years in Practice ASBM - US Prescribers and Biosimilars Naming

6. Therapeutic specialty • “Please indicate your primary practice area or therapeutic area in which you practice.” ASBM - US Prescribers and Biosimilars Naming

7. Volume of patient visits • “On average, about how many patient visits do you conduct per week?” ASBM - US Prescribers and Biosimilars Naming

8. Familiarity with Orange Book • Question • “How familiar are you with the “Orange book”, that is, the resource for Approved Drug Products with Therapeutic Equivalence Evaluations?” ASBM - US Prescribers and Biosimilars Naming

9. Frequency of Orange Book use • Question • “How often in your work do you use or refer to the “Orange Book”?” ASBM - US Prescribers and Biosimilars Naming

10. Familiarity with Purple Book • Question • “How familiar are you with the “Purple Book”, that is, the resource for Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations?” ASBM - US Prescribers and Biosimilars Naming

11. Frequency of Purple Book use • Question • “How often in your work do you use or refer to the “Purple Book”?” ASBM - US Prescribers and Biosimilars Naming

12. ASBM Drug recording practices

13. Prescribe biologics? • Question • “Do you prescribe biologic medicines in your practice?” ASBM - US Prescribers and Biosimilars Naming

14. Others’ patients? • Question • “Do you commonly treat patients who you are aware are being prescribed biologic medicines by another health care provider?” ASBM - US Prescribers and Biosimilars Naming

15. Identify in patient record – Someone else’s patient • Question • “When you treat a patient receiving a biologic medicine prescribed by another health care provider, do you identify the medicine in the patient record?” (N=309, those who commonly treat patients being prescribed biologic medicines by another health care provider) ASBM - US Prescribers and Biosimilars Naming

16. Identify in patient record? • Question • “When you prescribe medicine, whether chemical or biologic, do you identify the medicine in the patient record?” ASBM - US Prescribers and Biosimilars Naming

17. How biologics are identified • Question • “When you identify a medicine for prescription or recording in a patient record, are you more likely to identify the medicine by brand name, non-proprietary / scientific name, or NDC number?” How does it vary? ASBM - US Prescribers and Biosimilars Naming

18. Identification for reporting AEs • Question • “Physicians play an important role in the identification and reporting unexpected or serious adverse events to FDA and manufacturers. In the context of identifying a biologic (or, if you don’t prescribe biologics, any other drug) for purposes of reporting an adverse event, would you prefer to identify the medicine by a product name or number (National Drug Code number)?” ASBM - US Prescribers and Biosimilars Naming

19. Recording changes in patient’s file • Question • “When a pharmacy contacts you regarding a change in the medicine a patient receives (for example, to request approval for a change due to insurance coverage), how often do you record that change in the patient's file?” ASBM - US Prescribers and Biosimilars Naming

20. ASBM Product Naming attitudes & beliefs

21. Structurally identical? • Question • “In the US, all medicines must have a non-proprietary scientific name upon approval. The manufacturer may choose to also designate a brand name for the product. If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that: • …the medicines are structurally identical?” ASBM - US Prescribers and Biosimilars Naming

22. Both produce same result? • Question • “In the US, all medicines must have a non-proprietary scientific name upon approval. The manufacturer may choose to also designate a brand name for the product. If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that: • …a patient could safely receive either product and expect the same result?” ASBM - US Prescribers and Biosimilars Naming

23. Switch with same result? • Question • “In the US, all medicines must have a non-proprietary scientific name upon approval. The manufacturer may choose to also designate a brand name for the product. If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that: • …a patient could be safely switched between the products during a course of treatment and expect the same result as treatment with only one of the products?” ASBM - US Prescribers and Biosimilars Naming

24. Biologic medicines are therapeutic proteins produced using living cells. A copy of an original biologic made by a different manufacturer is referred to as a biosimilar or follow-on biologic rather than a generic because it will be similar, not identical, to the product it copies. Biosimilars are also referred to as subsequent entry biologics (SEBs) in Canada. In short, biosimilars are “copies” of biologic medicines, whereas traditional “generic” medicines are generally based on chemical products. As a result of the new biosimilar pathway to approval, biosimilar medicines are now available in the US market. Biosimilars intro

25. Familiarity with biosimilars • Question • “How familiar are you with biosimilar medicines?” ASBM - US Prescribers and Biosimilars Naming

26. Awareness of biosimilarsapproval process • Question • “Originator medicines are approved by the US Food and Drug Administration based on an evaluation of clinical data that demonstrates a medicine is safe and effective for the specified indication and data must be provided for every indication. The approval pathway for biosimilars is different than for originator medicines. Are you aware a biosimilar medicine may be approved for several or all indications of the reference product on the basis of clinical trials in only one of those indications?” ASBM - US Prescribers and Biosimilars Naming

27. Acceptability of biosimilars approval process • Question • “How do you feel about the fact that a biosimilar medicine may be approved for several or all indications of the reference product on the basis of clinical trials in only one of those indications?” ASBM - US Prescribers and Biosimilars Naming

28. Should FDA require distinct names? • Question • “The FDA has proposed a new policy that would require every biologic – whether originator or biosimilar – to have a distinct non-proprietary scientific name. In your opinion, should the FDA require a distinct non-proprietary scientific name for every biologic product – whether originator or biosimilar – approved by them?” ASBM - US Prescribers and Biosimilars Naming

29. Representative or random suffix? • Question • “The FDA has proposed a policy that would require the use of a distinct non-proprietary scientific name for all products, whether originator or biosimilar. This is intended to aid the process of pharmacovigilance and accurate prescribing and dispensing of medicines. In March of 2015, the FDA approved the first biosimilar product for the U.S. market. The product currently carries the scientific name “filgrastim-sndz.” In the case of filgrastim-sndz, the suffix “sndz” is intended to identify Sandoz as the manufacturer of the product. More recently, the FDA has proposed a further change to the naming of biologic products. In the case of filgrastim-sndz, the name would become “filgrastim-bflm,” where the suffix carries no meaning and is not indicative of the product’s manufacturer. For future product approvals, which of the following would you prefer?” ASBM - US Prescribers and Biosimilars Naming

30. Why representative / random? See verbatim responses in attached MS Word file. ASBM - US Prescribers and Biosimilars Naming

31. Suffix content • Question • “For purposes of accurately identifying the medicine, a representative suffix – for example, one that resembles the manufacturer name – is preferable.” • Question • “For purposes of accurately identifying the medicine, I prefer a suffix that is a random 4-digit string of characters.” ASBM - US Prescribers and Biosimilars Naming

32. ASBM Substitution attitudes & beliefs

33. Importance of DAW authority • Question • “Every state gives the prescriber the authority to specify that a generic chemical drug may not be substituted without contacting the prescriber, for example by specifying “DO NOT SUBSTITUTE” or “DISPENSE AS WRITTEN”. How important is it to you to have the authority to designate a biologic medicine as "DISPENSE AS WRITTEN" or "DO NOT SUBSTITUTE"?” ASBM - US Prescribers and Biosimilars Naming

34. Importance of notification • Question • “Some states require the pharmacist to notify the prescribing physician if a product other than the one prescribed is dispensed at the pharmacy. How important is it to you to be notified by the pharmacist if your patient receives a biologic medicine other than the one you prescribed?” ASBM - US Prescribers and Biosimilars Naming

35. Importance of notification – with awareness • Question • “How important would it be for you to be notified by the pharmacist that your patient has received a biologic other than the one you prescribed if you were aware that the product could cause an unwanted immune response in some patients or that small differences between brands could have clinical implications for patients?” ASBM - US Prescribers and Biosimilars Naming

36. Preferred timeline for notification • Question • “At what point would you prefer to be notified of a change in the biologic medicine dispensed?” ASBM - US Prescribers and Biosimilars Naming

37. Why not important? • Question • “Why is it not important to you to be notified of a change from the medicine you prescribed?” (N=11, those who rate 4 or lower on importance of notification) ASBM - US Prescribers and Biosimilars Naming

38. Preference for contact? • Question • “How do you prefer to be contacted by a pharmacy about prescription changes? Please select one.” ASBM - US Prescribers and Biosimilars Naming