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Current human insulin and human insulin analogue situation

15 August 2005

Two major suppliers of insulin in Australia have recently removed a number of products from the Australian market.

Novo Nordisk has advised the Therapeutic Goods Administration (TGA) that it is removing Monotard and Ultratard from the market in 2005. The two products are insulin zinc suspension products and are used less often than newer insulin presentations. The two products will be discontinued from the Pharmaceutical Benefits Scheme (PBS) in August 2005.

Novo Nordisk has embarked on an extensive information program in relation to this decision. This involved individual prescribers who frequently use these insulins, as well as Diabetes Australia and the health professionals in general. Transfer guidelines to facilitate patient movement to other products have been developed with the representative Australian professional bodies.

Eli Lilly is discontinuing Humulin Ultralente, Humulin Lente and Humulin 50:50 in Australia. These products were discontinued from the PBS in April 2005. The sponsor advises that the products have already been discontinued in Europe. Eli Lilly indicated a steady decline in the use of Humulin Ultralente, Humulin Lente and Humulin 50:50 in the past few years. This decline in conjunction with the introduction of alternative therapies has led to the decision to discontinue these products in Australia.

It should be noted that the decision to discontinue these products has been made by the companies on commercial grounds and is not a result of regulatory action on the part of the TGA. It was not an Australian specific decision, but international.

The Australian Government cannot force a company to manufacture or supply a product against its will.

It is expected that nearly all patients will be able to be transferred to new insulin products. Patients affected by the removal of the products are advised to contact their doctor for further information on a suitable alternative.

A list of currently available Human insulin and Human insulin analogues is below.

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Current Human Insulin and Human Insulin Analogue Products
Brand name Presentation Insulin Type Sponsor Pharmaceutical Benefit Listing
LANTUS

Insulin glargine (rbe) solution for injection

  • Present as: Injector pen OPTISET and OptiClik 3mL, cartridges 3mL
  • Vials 5 and 10mL
 Long acting Insulin analogue Aventis Pharma Pty Ltd Not on PBS and not all may be marketed
Humulin UL
Humulin 50/50

Insulin Neutral-Insulin Isophane (N.P.H.) (Mixed) (Biphasic Isophane)

  • injection (human) 100 units (50 units-50 units) per mL, 10 mL vials,
 Mixed fast and intermediate - long acting Eli Lilly Deleted by sponsor from Schedule of Pharmaceutical Benefits and from the market
Humulin UL

Insulin Zinc Suspension (Crystalline) (Ultralente)

  • injection (human) 100 units per mL, 10 mL vials
 Long acting Eli Lilly Deleted by sponsor from Schedule of Pharmaceutical Benefits and from the market
Humulin L

Insulin Zinc Suspension (Lente),

  • injection (human) 100 units per mL, 10 mL vials
 Long Acting Eli Lilly Deleted by sponsor from Schedule of Pharmaceutical Benefits and from the market
Humalog

INSULIN LISPRO Injection (human analogue)

  • 100 units per mL, 10 mL vials
  • Injections (human analogue) 100 units per mL, 3 mL cartridges,
 Fast Acting Eli Lilly Marketed and on the PBS
Humulin R

INSULIN NEUTRAL (also known as soluble or regular insulin)

  • Injections (human) 100 units per mL, 3 mL cartridges, 10 mL vials,
 Fast Acting Eli Lilly Marketed and on the PBS
Humulin NPH

INSULIN ISOPHANE (N.P.H.)

  • Injection (human) 100 units per mL, 10 mL vials
  • Injections (human) 100 units per mL, 3 mL cartridges,
 Intermediate Acting Eli Lilly Marketed and on the PBS
Humalog Mix25

INSULIN LISPRO-INSULIN LISPRO PROTAMINE SUSPENSION

  • Injections (human analogue) 100 units (25 units-75 units) per mL, 3 mL cartridges
 Insulin analogues, intermediate-acting combined with fast-acting: Eli Lilly Marketed and on the PBS
Humulin 30/70

INSULIN NEUTRAL-INSULIN ISOPHANE (N.P.H.), (MIXED)

  • Injection (human) 100 units (30 units-70 units) per mL, 10 mL vials, 3mL cartridges
 Insulins, human, intermediate-acting combined with fast-acting Eli Lilly Marketed and on the PBS
Humulin 50/50 INSULIN NEUTRAL-INSULIN ISOPHANE (N.P.H.), (MIXED) Insulins, human, intermediate-acting combined with fast-acting Eli Lilly Deleted by sponsor from Schedule of Pharmaceutical Benefits and from the market
Ultratard

Insulin Zinc Suspension (Crystalline) (Ultralente),

  • injection (human) 100 units per mL, 10 mL vials
   Novo Nordisk Deleted from the market and from the Schedule of Pharmaceutical Benefits (Available as a pharmaceutical benefit until 1 August 2005)
Monotard

Insulin Zinc Suspension (Lente),

  • injection (human) 100 units per mL, 10 mL vials
   Novo Nordisk Deleted from the market and from the Schedule of Pharmaceutical Benefits (Available as a pharmaceutical benefit until 1 August 2005)
NovoRapid

INSULIN ASPART Injection (human analogue)

  • 100 units per mL, 10 mL
  • NovoRapid FlexPen Injections 100 units per mL, 3 mL,
  • NovoRapid Penfill 3 mL
 Fast Acting Novo Nordisk Marketed and on the PBS
Actrapid

INSULIN NEUTRAL (also known as soluble or regular insulin)

  • Injections (human) 100 units per mL, 3 mL cartridges,
 Fast Acting Novo Nordisk Marketed and on the PBS
Protaphane

INSULIN ISOPHANE (N.P.H.)

  • Injection (human) 100 units per mL, 10 mL vials
  • Protaphane Penfill, InnoLet and NovoLet Injections (human) 100 units per mL, 3 mL cartridges,
 Intermediate Acting Novo Nordisk Marketed and on the PBS
Novomix 30

INSULIN ASPART-INSULIN ASPART PROTAMINE SUSPENSION

  • Injections (human analogue) 100 units (30 units-70 units) per mL, 3 mL Penfill and FlexPen
 Insulin analogues, intermediate-acting combined with fast-acting Novo Nordisk Marketed and on the PBS
Mixtard 30/70

INSULIN NEUTRAL-INSULIN ISOPHANE (N.P.H.), (MIXED)

  • Injection (human) 100 units (30 units-70 units) per mL, 10 mL vials and Penfill 3 mL and InnoLet 3mL
 Insulins, human, intermediate-acting combined with fast-acting Novo Nordisk Marketed and on the PBS
Mixtard 50/50

INSULIN NEUTRAL-INSULIN ISOPHANE (N.P.H.), (MIXED)

  • Injection (human) 100 units (50 units-50 units) per mL, 10 mL vials and Penfill 3 mL
 Insulins, human, intermediate-acting combined with fast-acting Novo Nordisk Marketed and on the PBS
Mixtard 20/80

INSULIN NEUTRAL-INSULIN ISOPHANE (N.P.H.), (MIXED)

  • Injections (human) 100 units (20 units-80 units) per mL, 3 mL Penfill
 Insulins, human, intermediate-acting combined with fast-acting Novo Nordisk Marketed and on the PBS
Levemir

Insulin detemir

  • 100IU/mL present as Innolet, Flexpen and Penfill cartridges. Only FlexPen 3mL cartridges are marketed.
 Long Acting Insulin Analogue Novo Nordisk Registered and Not on PBS

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