Generic Drugs, Brand Prescribing & Biosimiliars

Items Unsuitable for Generic Prescribing

The following list provides examples of drugs/preparations which the Medicines Management Advisors would NOT recommend for generic prescribing.

Source: hscboard.hscni.net

Clinical Resource: Guidance

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Last Checked: 22/11/16

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North of Tyne & Gateshead Area Prescribing Committee Guideline on Medicines that are Not Suitable for Generic Prescribing

Source: northoftyneapc.nhs.uk

Clinical Resource: Guideline

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Last Checked: 22/11/16

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Which medicines should be considered for brand-name prescribing in primary care?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals

The following table lists medicines that might be considered for brand-name prescribing. This table has been compiled using a number of sources.

Source: sps.nhs.uk

Clinical Resource: Medicines Question and Answer

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Last Checked: 22/09/16

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Drug Patent Expirations and the “Patent Cliff”

Selected drugs whose patents have expired or will expire over the next several years are shown in TABLE 1 .

Source: uspharmacist.com

Clinical Resource: Journal Article

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Last Checked: 22/11/16

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Brand Name Drug Patent Expiration

Brand-Name Drug Patent Expiration Search

Source: q1medicare.com

Clinical Resource: Database

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Last Checked: 22/11/16

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The Association of the British Pharmaceutical Industry Biosimilars Position Paper

To support its members, the ABPI has updated its position paper on biosimilar medicines which cover areas where action is needed by regulators, HTA agencies, NHS commissioners and NHS healthcare professionals who prescribe or dispense biosimilar medicines.

Source: abpi.org.uk

Clinical Resource: Position Paper

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Last Checked: 22/11/16

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Understanding biological & biosimilar medicines

Answers to frequently asked questions regarding biological & biosimilar medicines.

Source: abpi.org.uk

Clinical Resource: Frequently Asked Questions

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Last Checked: 22/11/16

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Biological and biosimilar medicines in the UK

Biological and biosimilar medicines in the UK: key points, biological medicines, ensuring patient safety, interchangeability and references.

Source: abpi.org.uk

Clinical Resource: Publication

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Last Checked: 22/11/16

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...about biosimilars

Biological medicines are generally far more complex than conventional pharmaceuticals – their structures can be difficult to characterise, and their production involves complicated manufacturing processes.

Source: wemerec.org

Clinical Resource: Reference

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Last Checked: 16/11/17

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What is Bioavailability and Bioequivalence?

If two medicines are bioequivalent there is no clinically significant difference in their bioavailability.

Source: bpac.org.nz

Clinical Resource: Journal Article

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Last Checked: 22/11/16

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Do Single Stereoisomer Drugs Provide Value?

Stereoisomers are molecules with one or more “chiral” centres that allow the possibility of forms with the same chemical formula but differing spatial arrangements.

Source: ti.ubc.ca

Clinical Resource: Evidence Based Therapeutics Letter

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Last Checked: 22/11/16

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Stereoisomerism

Stereoisomers are molecules that have one or more ‘chiral’ centres, meaning that the molecule can have the same chemical formula, but can have a different spatial arrangement of the atoms.

Source: auspharmlist.net.au

Clinical Resource: Pharmacy E-Bulletin

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Last Checked: 22/11/16

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Inside the isomers: the tale of chiral switches

Drug companies are increasingly using chiral switching as a marketing strategy, but before prescribers switch to single enantiomer drugs they should look for evidence from well-conducted clinical trials that shows the chiral switch is cost-effective and improves the outcomes for patients rather than patents.

Source: nps.org.au

Clinical Resource: Journal Article

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Last Checked: 22/11/16

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Escitalopram or citalopram for depression in primary care?

Several independent reviews of randomised controlled trials (RCTs) have concluded that the benefits of escitalopram over other antidepressants are small and unlikely to be clinically significant.

Source: webarchive.org.uk

Clinical Resource: National Prescribing Centre Publication

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Last Checked: 22/11/16

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Antiepileptics: changing products : MHRA

This section of the website provides information about switching between manufacturers’ products of antiepileptic drugs, including switching between branded products and generic products, and between different generic products of a particular drug.

Source: webarchive.nationalarchives.gov.uk

Clinical Resource: Various

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Last Checked: 22/11/16

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Epilepsy Action Position Statement on the Consistency of Supply

Source: epilepsy.org.uk

Clinical Resource: Position Statement

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Last Checked: 22/11/16

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Epilepsy Society of Australia Position Statement: Generic drug use in epilepsy

Source: epilepsy-society.org.au

Clinical Resource: Position Statement

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Last Checked: 22/11/16

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Generic AEDs: Current Standards and Recommendations

Switching AED Formulations: Defining the Issues

Understanding the Ramifications of Switching Among AEDs: What Are the Data?

Roundtable Discussion

Source: utasip.com

Clinical Resource: Review Articles and Roundtable Discussion

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Last Checked: 22/11/16

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What are the differences between different brands of mesalazine tablets?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals

Available formulations have differences in licensed indications, tablet strengths, dose frequency, interactions, pharmaceutical, pharmacological and pharmacokinetic properties.

Source: sps.nhs.uk

Clinical Resource: Medicines Question and Answer

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Last Checked: 22/09/16

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What are the differences between non-oral mesalazine preparations?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals

The locally acting preparations that are currently available are liquid and foam enemas and suppositories which are inserted in to the rectum. Available formulations have differences in licensed indications, strengths, and dose frequency.

Source: sps.nhs.uk

Clinical Resource: Medicines Question and Answer

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Last Checked: 22/09/16

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Generic Latanoprost Prescribing
The Royal College of Ophthalmologists

The patent for Xalatan® expired on 17 January 2012. The MHRA has granted Pfizer and twenty other companies licences for generic latanoprost production.

Source: rcophth.ac.uk

Clinical Resource: Statement / Advice

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Last Checked: 22/11/16

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Generic and originator immunosuppressants ­ comparative list prices and bioequivalence data

Collation of comparative bioequivalence data for ciclosporin, tacrolimus and mycophenolate mofetil products plus NHS list prices as quoted in MIMS.

Source: esprit.org.uk

Clinical Resource: List and Data

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Last Checked: 22/11/16

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Generic Immunosuppressants in the Specialist Area of Transplantation – Consensus on Implications and Practical Recommendations
Efficacy and Safety of PRescribing In Transplantation

Source: esprit.org.uk

Clinical Resource: Consensus Document

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Last Checked: 22/11/16

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Leicestershire Medicines Strategy Group Guideline
Leicestershire Statement on the use of Generic Immunosuppressants in people following Renal Transplantation

Source: lmsg.nhs.uk

Clinical Resource: Guideline

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Last Checked: 22/11/16

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ESPRIT Ciclosporin-Specific Resources

Following the introduction of alternative formulations of ciclosporin into the UK, please find below some materials that will help to communicate the potential complications that could result if a patient were inadvertently switched between ciclosporin brands.

ESPRIT Prescribing Recommendations (Extended)
ESPRIT Prescribing Recommendations (Summary)
Patient Letter
GP Letter
Transplant Clinic Poster
Patient Leaflet
Treatment Reminder Card

Source: esprit.org.uk

Clinical Resource: Various

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Last Checked: 22/11/16

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Tacrolimus / ciclosporin - Prescribe by brand only

It is recommended that certain drugs are prescribed by brand due to variations in bioavailability and other reasons, such as formulation differences, which can lead to serious patient harm should the wrong product be dispensed against a generic prescription.

Source: coventrywarksapc.nhs.uk

Clinical Resource: Bulletin

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Last Checked: 22/11/16

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