Wednesday, October 31, 2012

Biocon Biosimilar human Insulin (Insugen) shows comparable efficacy and safety compared to Novo Nordisk's Human Insulin in a Global Phase 3 study

In a multi center Phase 3 study involving 300 Type 1 diabetes mellitus patients, Biocon’s Regular human Insulin (Insugen R®) and Isophane human Insulin (Insugen N®) was compared to Novo Nordisk's human insulin products(Actrapid® and Insulatard®) sourced from Europe. The trial met its efficacy end-point by demonstrating non-inferiority in HbA1c endpoint at 6 months. Immunogenicity and safety as evaluated by hypoglycemic events at the 6 month time point were also similar.

Market Potential for Biosimilar Human Insulin

The global market for Human Insulin is close to $3billion and comprise approximately 40% of the insulin volume sales and 20% by value. Human insulin is being gradually replaced by Modern insulins. Novo Nordisk has about 75 percent volume share of the human insulin market.

Barriers to Biosimilars in Insulin Market

1)Significant usage of modern pen devices

2)Strong brand loyalty and limited switching between therapies

3)Many prescribers requiring significant commercial operations

4)High volume production with significant capital investment required

5)Limited abbreviated regulatory pathways for approval of biosimilar insulin

Existing Biosimilar Player in Human Insulin having a global presence
Tonghua Dongbao Group has successfully developed China's first recombinant human insulin in 1998. At present, the recombinant DNA human insulin line of products made by Dongbao has been registered and certified in over 20 countries including Russia, Poland, Mexico, Brazil and Ukraine. From 2001 to present day, freeze-dried powders and preparations of Tonghua Dongbao human insulin generates around $50 million in sales from international markets (outside China). Globallly Tonghua has about 8 percent market share in the human insulin space. In 2010, Tonghua launched a reusable pen (ServoPen, developed by Ypsomed)under the brand name Gansulin. The Ypsomed Group is a leading company for the development and manufacturing of delivery systems for self-medication and a key supplier with a broad product portfolio in the field of diabetes care

Tonghua Dongbao is vigrously expanding - Investing More Capital
Tonghua Dongbao Pharmaceutical Co., Ltd. is investing to increase its annual production capacity of recombinant human insulin injections of 126 million to lift the company's annual production capacity of 200 million human insulin injections
The expansion will help Tonghua generate annual operating revenue of RMB 5.138 billion (USD 800m) and profits of RMB 1.692 billion (USD 250m).

Biocon Market Share Prospects would largely depend on

1) Delivery device.
Delivery devices have a major role in shaping patients' experiences with insulin, as they affect comfort, convenience, adherence, and outcomes. Novo, Sanofi and Lilly have developed devices that allow less painful and more precise insulin administration. It is unlikely that biosimilar companies would be able to provide a device that would match the benchmarks set by innovators, hence it substitution will be impacted to that extent. Physicians would be less interested in adopting a biosimilar product if it is less convenient to use than a reference product as it can impact adherence to insulin therapy

2)Pricing issues and Interchangeability

Price obviously will influence demand, hence the extent of discount would be crucial. It may not be possible for insulin biosimilars to offer a discount comparable to small molecule generics, hence the demand would be impacted to an extent. We have seen biologics in the European market for over five years now, but the disocunt is limited and hence the market share as well. On an average Biosimilars take less than 10% of the branded market share.

In a reimbursed market, the biosimilars should allow substantial savings for customers in terms of out of pocket costs, which may be difficult. Payors may be able to offer a higher formulary status to biosimilars only if they are interchangeable and offer the same therapeutic value (convenience, compliance, effiacy and safety ) as brand names. Products not deemed interchangeable are likely to be treated like branded entries into the class, which would make formulary inclusion more difficult and reimbursement less probable. Biosimilar insulin products which achieve an interchangeable rather than just a biosimilar designation may have to bear relatively fewer marketing and education costs, hence can offer steeper discounts, leading to enhanced penetration. Biocon may not be able to match innovators on delivery device sophistication, hence an interchangeable status may not be possible
Newly diagnosed patients who rely more heavily on physicians in their decision-making may be relatively more likely to initiate or switch to biosimilars, even if cost differentials are only moderate.

Amount of Discount would be limited
The expenses associated with executing a biosimilar's complex manufacturing process and clinical evaluations will lead to lower discounts. Unlke a generic for a NCE, which requires minimal ( $1–2 million ) investment before approval, the cost of bringing a follow-on biologic to market could be anywhere from ~ $30 to $150 million.
Per-unit manufacturing costs for insulin are ~ $50–75 per gram versus $5 per gram for chemical drugs. Consequently, price reductions for biosimilars are only expected to be ~ 20–40%, with some reduction estimates ranging as low as 10% and as high as 70%.

Emerging Markets - A Potential market for Biosimilars in the near term
Emerging Markets, which are primarily out of pocket markets constitute an attractive market for Insulin Biosimilars. Even a 30-40% discount to innovator drugs, would help biosimilars carve a decent share. Allowing for device related constraints, Biocon should be able to capture about 5-10 percent market share in emerging markets.

Other biosimilar Players in the fray for a share of the insulin biosimilar market
Bayer and Wockhardt should are also expected to report data on their recombinant human insulins over the next one year.

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