バイオシミラーへの対抗策：オプションの評価

生物学的治療は医療市場の主力部門となるまでに成長してきましたが、バイオシミラーの商業面での影響度は、現在までのところ非常に小さいままとなっています。しかし、状況は変化し始めています。例えば、売上高の大きな医薬品5種類（合計350億米ドル分）の特許がまもなく失効するため、バイオシミラー製品の参入と激しい競争が予想されます。

当レポートでは、世界の生物製剤市場にいて、各社がバイオシミラーとの競合に関する問題について分析・評価し、その結果を概略以下の構成でお届けします。

分析項目

• 米国市場におけるバイオシミラーの登録：州ごとの違い
• 欧州における2種類の主なバイオシミラー製品の導入：主な違い
• 特許無しでのアプローチ：独占性、ロビイング、市民からの嘆願活動、相互互換性など
• ブランド約市場ではどのようなマーケティング・価格戦略が導入できるのか？
• バイオベターの開発による技術的主導権

主な問題意識

• 有効な特許なしに、どうやって市場での独占的地位を維持できるのか？
• なぜ、バイオテクノロジー企業の中でバイオシミラー企業と提携するものが現れるのか？
• 米国の新たな法制手順は、バイオシミラー製品の開発企業にどのような影響を与えるのか？
• バイオシミラーの参入を遅らせるために、どのような戦術を採ればよいのか？
• より混雑した市場で、自社のブランド生物製剤に対するロイヤルティをどうやって構築するのか？

分析のハイライト

• バイオシミラー製品の開発・販売の最新動向
• 考察：バイオシミラーの商業的影響度はなぜ今日まで限られてきたのか、そして今後は変化し得るのか
• 防衛戦略が特に必要となる、大手企業7社の概要
• バイオシミラーの参入を阻止・遅延させるための戦術と実例
• 防衛側企業の売上高・マーケティング・価格設定・薬剤開発戦略

Abstract

Although biological therapeutics have developed into an increasingly valuable segment of the pharmaceutical market, the commercial impact of biosimilar products has, to date, been fairly insignificant. However, thats set to change.

Five of the world' s best selling innovator drugs, with collective sales of $35 billion in 2012, will shortly lose patent protection, making them vulnerable to biosimilar competition. Developers of biosimilars will also benefit from the recent establishment of an abbreviated regulatory pathway for the approval of biosimilars in the United States.

With the biosimilar market on the brink of expansion, FirstWord Dossier has recognised the need for robust guidance on defensive strategies, focusing on two main areas: delaying approval of competing biosimilars; and sustaining product revenues in the face of the competitive challenge.

In creating this unique report, FirstWord sought expert opinions on factors that have influenced decisions to date and how these will impact further developments.

Biosimilar Defensive Plays -- assessing the options is an essential resource for biotechnology executives who need to understand the challenges and opportunities presented by biosimilars.

Key Benefits

Generic defence strategies are well documented, but many of these are either less relevant or inapplicable to biosimilars. With Biosimilar Defensive Plays -- assessing the options, you will learn which generic defence strategies are effective against biosimilars, and which contexts call for specific biosimilar defence strategies. You'll also be informed about how different strategies may be appropriate according to interchangeability status, orphan drug status, and whether the product is a paediatric therapy. This insightful report brings you completely up to date with the biosimilar competitive landscape, and gives you the information you need to strengthen your brand and sustain revenues against an emerging threat. Specific topics addressed include:

• State-by-state variations of biosimilar legislation in the U.S. market
• The pronounced difference in the uptake of the two main biosimilar products in Europe
• Non-patent approaches, e.g., exclusivity, lobbying, citizen petition, and interchangeability
• Which marketing and pricing strategies can be adapted from the branded drug market
• Technological leadership through the development of biobetters

Key Quotes

"On the production side, process patents and the technology they cover could be core to the production of a particular biosimilar and they could well expire well after he actual product use patent, so that's been an interesting lesson learnt." Steven Flatman, head of R&D Biosimilars, Lonza Biologics

"Companies have used their market strength and relationships with key stakeholders to present a negative perception about biosimilars. They especially stressed data on the poor quality of copy biological products produced in Southeast Asia, and used this to imply that biosimilars approved in the EU would be of poor and variable quality." Paul Greenland, vice president, Biologics, Hospiram

"The very firm, thick, black lines between being an originator company and a generic company are getting much thinner and fainter, and we are just going to see people coming to the market with a range of products competing in a different way." Warwick Smith, director-general, British Generic Manufacturers Association

Biosimilar Defensive Plays -- assessing the options is designed to answer your strategic and tactical questions, such as:

• How can I sustain market exclusivity without a valid patent?
• Why are some biotechnology companies partnering with biosimilar companies?
• What does the new U.S. regulatory pathway for biosimilars mean for developers of these products?
• What tactics can we employ to delay market entry of biosimilars?
• How can we build brand loyalty for our branded biologic in a more crowded marketplace?

Expert Views Include:

• John Ansell , director, John Ansell Consultancy
• Sandy Eisen , chief medical officer, Frontline Pharma Consulting
• Steven Flatman , head, R&D Biosimilars, Lonza Biologics
• Paul Greenland , vice president, biologics, Hospira
• A portfolio development PM for autoimmune diseases within a German-based pharmaceutical company
• Diem Nguyen , general manager, biosimilars business unit, Pfizer
• Warwick Smith , director-general, British Generic Manufacturers Association

Report Highlights

• Up-to-date summary of biosimilar product development and sales
• Insights into why biosimilars have had limited commercial impact to date, and how that will change
• A look at seven major companies in particular need of defensive strategies
• Tactics for delaying or preventing approval of biosimilars-with real-world examples
• Defensive sales, marketing, pricing, and drug development strategies