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Dean Rudge

Under the guidance of editor Aidan Fry and deputy editor David Wallace, Dean has built up a wealth of knowledge on the global generics and biosimilar medicines industries in his five years with Generics bulletin. He specializes in commercial and legal issues, writing in-depth analyses of corporate strategy and getting under the skin of patent-infringement proceedings and other litigation. He attends investor and regulatory meetings with business leaders, favoring the investor days with their focus on corporate strategy. In his spare time, Dean enjoys visiting museums and playing five-a-side football.
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Adcock Unhappy With Single Exit Price But Scoops ZAR1.8bn From ARV Tender

Growing its portfolio of established brands and expanding its product range through the acquisition of non-regulated brands are at the top of Adcock Ingram’s wish-list in 2019, as the company grapples with what it feels is a “low” increase in South Africa’s single exit price and tough trading conditions in certain channels. Nevertheless, it saw a “sound” financial performance in the six months to 31 December 2018.

Strategy South Africa

Canadian Authorities Say Janssen Did Not Choke Competition For Infliximab – But Will Keep Spotlight On Originator Abuse Of Power

In contrast to a US court, the competition authority in Canada has not found evidence that Janssen abused its power in the infliximab market and unlawfully stymied competition from Pfizer’s and Merck’s biosimilars. However, given the relative immaturity of the Canadian biosimilars market, the Competition Bureau said it would continue to watch closely as the market develops.

Biosimilars Canada

Teva Barred From Agreeing ‘No-Authorized Generics’ Deals Under Reverse-Payment FTC Settlement

Modifying terms to a 2015 consent decree involving its Cephalon unit, Teva has reached a global settlement agreement with the US Federal Trade Commission that dismisses Teva and its affiliates from three outstanding antitrust cases.

United States Strategy

Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know

In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.

Biosimilars FDA

Pfenex One Step Closer To Teriparatide As FDA Accepts NDA

Pfenex maintains it can introduce a follow-on version of Eli Lilly’s Forteo in the fourth quarter of this year, after receiving a target goal date of 7 October 2019 from the FDA.

Value-Added Medicines FDA

Glenmark Plans To Spin Out A US-Based ‘Innovation’ Business – And May Pull The Plug On Advair

Having amassed a significant pipeline of innovative assets, India’s Glenmark has made the choice to spin them off into a new company that will be housed in the US. 
Strategy Biosimilars
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