Ouch! Federal Court of Australia imposes $4.5 million-dollar penalty for misleading marketing of pain-relief products

The Federal Court has handed down a significant $4.5 million penalty over misleading claims made with respect to the over-the-counter muscular pain relief products, ‘Voltaren Osteo Gel’ and ‘Voltaren Emulgel’.  The decision in Australian Competition and Consumer Commission v GlaxoSmithKline Consumer Healthcare Australia Pty Ltd (No 2) [2020] FCA 724 makes it clear that the read more...

Australian company ordered to pay $10 million for unacceptable advertising claims: TGA uses its power to penalise inappropriate online advertisement and sale of therapeutic goods

Justice Jagot found Peptide Clinics Pty Ltd (Peptide Clinics) (now in liquidation) had contravened several provisions of the Therapeutic Goods Act 1989 (Cth) (TG Act), including making claims that breached the Therapeutic Goods Advertising Code.  Justice Jagot has ordered Peptide Clinics to pay a pecuniary penalty to the Commonwealth of $10 million in respect of the contraventions. read more...

United States FDA gets serious about biosimilars

The most significant advances in medical treatments are being made with biological products.  As biological medicines are significantly more expensive than traditional small molecule drugs, upward pressure is being placed on health spending. For example, in the United States, biological medicines accounted for 40% of all prescription drugs spending and 70% of the increase in read more...
Subjects: Patents

Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised read more...
Subjects: Uncategorized